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Pharmacological agents for preventing morbidity associated with the haemodynamic response to tracheal intubation

  1. Fauzia A Khan*,
  2. Hameed Ullah

Editorial Group: Cochrane Anaesthesia, Critical and Emergency Care Group

Published Online: 3 JUL 2013

Assessed as up-to-date: 1 JUN 2011

DOI: 10.1002/14651858.CD004087.pub2


How to Cite

Khan FA, Ullah H. Pharmacological agents for preventing morbidity associated with the haemodynamic response to tracheal intubation. Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD004087. DOI: 10.1002/14651858.CD004087.pub2.

Author Information

  1. Aga Khan University Hospital, Department of Anaesthesiology, Karachi, Sindh, Pakistan

*Fauzia A Khan, Department of Anaesthesiology, Aga Khan University Hospital, Stadium Road, PO Box 3500, Karachi, Sindh, 74800, Pakistan. fauzia.khan@aku.edu.

Publication History

  1. Publication Status: New
  2. Published Online: 3 JUL 2013

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Characteristics of included studies [ordered by study ID]
Abdel-Razek 1991

MethodsRandomized, double blind, placebo controlled study


Participants36 ASA 1 and 2 patients. Both males and females included. Mean age 29-30. Nine years across groups


InterventionsGP I - Control
GP II - Nifedipine 10 mg sublingual
GP III - Fentanyl 1.5 ug kg-1 IV


OutcomesArrhythmias


NotesDuplication of publication (See reference to included studies). Written to author, no response


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "36 patients...... were randomly allocated into three groups" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: "This double blind study ..." in methods

"Induction of anaesthesia and the whole experiment was done by the other anaesthetist who did not know which of the three drugs had been given to the patient"

It is unlikely that the participants were blinded as two groups received IV medication and one group received sublingual

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Induction of anaesthesia and the whole experiment was done by the other anaesthetist who did not know which of the three drugs had been given to the patient"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Ali 2009

MethodsRandomized placebo controlled double blind


Participants50 normotensive ASA 1 patient. Both male and female patients included. Mean age 29-30 years


InterventionsGGP I - Placebo

GP II - gabapentin 1200 mg oral


OutcomesArrhythmia and myocardial ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomly allocated according to computer generated randomization to receive either placebo capsule or gabapentin"

Allocation concealment (selection bias)Low riskQuote: "The study drugs were prepared by the pharmacy and appropriate code numbers were assigned"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: 'The study design was ....double blinded"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "The staff involved in data collection and patient management were unaware of group assignment"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskDysrhythmia was defined in methodology but insufficient information regarding ischaemia

Amar 1991

MethodsRandomized, double blind, placebo controlled study


Participants16 ASA 1 women undergoing elective intra-abdominal surgery


InterventionsGP I - Control
GP II - Labetalol 0.15 mg/kg + 0.25-0.3 mg/kg every 3 minutes as required


OutcomesArrhythmias


NotesThis remark was supported in part by Chemical Research Centre Grant and an Educational grant by Key Pharmaceuticals. One of the authors was supported by National Institute of Health


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were allocated randomly to two treatment groups" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskBlinding mentioned in methods

Quote: "The anaesthetist was blinded as to...."

Patients were anaesthetized

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Artru 1985

MethodsRandomized, unblinded, controlled


Participants45 patients, both males and females. Mean age range between 38.5-40.5 years


InterventionsGP I - No spray

GP II - Etidocaine 50 mg aerosol

GP III - Etidocaine 75 mg aerosol


OutcomesArrhythmias


NotesASA status not known


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "randomized" mentioned in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding mentioned

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessor blinded for ECG

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Asfar 1990

MethodsRandomized, controlled, unblinded


Participants80 ASA I and II patients for elective surgery


InterventionsGroup I - Control

Group II - Lidocaine 10%, 1 mg.kg-1 with spray atomizer

Group III - Lidocaine 4%, 1 mg.kg-1 trans tracheal

Group IV - Lidocaine 2%, 1 mg.kg-1 IV


OutcomesArrhythmias and ST segment depression and T wave inversion


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "randomly assigned" mentioned in methods but no details

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskBlindng not mentioned

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskBlinding not mentioned

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Atlee 2000

MethodsRandomized, controlled, unblinded


Participants104 patients of both genders. Mean range 42-49 years across groups


InterventionsG I - Esmolol mg kg-1

G II - Nicardipine 3 mg IV

G III - No treatment


OutcomesArrhythmia


NotesASA status not known. Fourth group of combined nicardipine and esmolol excluded


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "randomization" mentioned in methodology

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information.No mention of blinding in methodology

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessor blinded, mentioned in discussion

Incomplete outcome data (attrition bias)
All outcomes
High riskFive patients excluded from analysis

Selective reporting (reporting bias)Unclear riskInsufficient information

Bafna 2011

MethodsProspective randomized double blind placebo controlled study


Participants90 normotensive ASA 1 and 2 patients


InterventionsGroup 1 - Placebo

Group II - Gabapentin 600 mg oral

Group III- Gabapentin 1000 mg oral


OutcomesArrhythmias


NotesOther ECG changes mentioned but nature of changes not identified


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskOnly random allocation mentioned

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding mentioned

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Bernstein 1989

MethodsRandomized, double blind, placebo controlled study


Participants24 ASA 1 and 2 patients, age 27-46 years scheduled for elective surgery


InterventionsGP I - Control
GP II - Labetolol 0.25 mg/kg IV
GP III - Labetolol 0.75mg/kg IV


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "They were randomized in a double blind fashion into one of three groups". No details of "randomization" mentioned

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding mentioned in methods. Quote: "They were randomized in a double blind fashion into one of three groups"

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Black 1984

MethodsRandomized, controlled, unblinded


Participants40 ASA 1 patients. Age 18-65 years


InterventionsGP I - Control. N Saline

GP II - Alfentanil 15 ug kg-1

Gp III - Alfentanil 30 ug kg -1

GP IV - Fentanyl 5 ug kg-1


OutcomesArrhythmia


NotesExclusion criteria not mentioned. An additional group of 10 patients did not receive any drug


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord random mentioned

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskDouble blinding not mentioned

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Carabine 1991

MethodsRandomized, double blind, placebo controlled study


Participants30 ASA 1 patients. Both males and females included. Mean age range 34-36 years across groups


InterventionsGP I - Clonidine 1.25 ug kg-1 IV
GP II - Clonidine 0.625 ug kg-1 IV
GP III - Control


OutcomesArrhythmias


NotesExclusion criteria not mentioned. No funding stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "And the patients were randomly allocated to one of three equal treatment groups"

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "In a placebo controlled randomized double blind trial" in summary

Quote: "All intubations were performed by the first author who was unaware of the identity of the test drug" in methods

Patients were anaesthetized at the time of drug administration

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Chraemmer-Jorgensen 1992

MethodsDouble blind randomized controlled trial


Participants24 patients without cardiopulmonary disorders (20-43 years)


InterventionsGroup 1: Saline

Group II: Alfentanil 100 mg kg-1 1 minute and 10 seconds before laryngoscopy


OutcomesST segment depression on ECG


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskGeigy's scientific tables of random numbers used

Allocation concealment (selection bias)Unclear riskMethod not described

Blinding of participants and personnel (performance bias)
All outcomes
Low riskTwo identical syringes were prepared by an anaesthesiologist not participating in the study

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information regarding dropouts

Selective reporting (reporting bias)Unclear riskNot pre-specified

Crawford 1987

MethodsRandomized, double blind, placebo controlled study


Participants44 patients undergoing major head and neck or thoracoabdominal surgery. Both males and females included. Mean age of patients 66.1 to 65.7 across groups


InterventionsG I - Control
G II - Alfentanil 10 ug kg -1IV
G III - Alfentanil 40 ug kg-1 IV


OutcomesArrhythmias
ECG evidence of ischaemia


NotesASA 3 patients


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were allocated randomly to receive IV ..." in methodology. No detail available

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Both observer anaesthetists were unaware of the nature of study drug". Participants under anaesthesia

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Both observer anaesthetists were unaware of the nature of study drug"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Cucchiara 1986

MethodsRandomized, double blind, placebo controlled study


Participants74 patients undergoing elective carotid endarterectomy


InterventionsGroup I - Esmolol 500 µg.kg-1.min-1 for 4 minutes then 300 ug.kg-1.min-1 for 8 minutes

Group II - Placebo


OutcomesArrhythmias and myocardial ischaemia


NotesMulti centre trial. High risk patients studies


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "randomized" mentioned in methods but details not mentioned

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding mentioned

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High risk12 patients were eliminated from data analysis due to deviation from protocol

Selective reporting (reporting bias)Unclear riskInsufficient information

Dahlgren 1981

MethodsRandomized, controlled, unblinded


Participants15 patients for elective neurosurgery. Both males and females included, mean age 49-54 years across groups


InterventionsGP I - Control

GP II - Fentanyl 5 µg kg-1


OutcomesArrhythmias and myocardial ischaemia


NotesNeurosurgical patients


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "random" mentioned in methodology

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskDouble blinding not mentioned. An unblinded study

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Davies 1981

MethodsRandomized, blinded, placebo controlled study


Participants20 patients undergoing a variety of intracranial procedures


InterventionsGP I - Hydralazine 0.4 mg kg-1 10 mins before induction

GP II - Control


OutcomesMyocardial Ischaemia


NotesHigh risk patients undergoing neurosurgery

The authors mention that CM5 lead used to detect myocardial ischaemia intraoperatively but do not mention the outcome in results. The results relate to BP and rate pressure product changes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The method of pretreatment was allocated randomly...". No details provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: "The method of pretreatment ..drug given was unknown to the investigators until the completion of study." No details provided

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)High riskThe authors mention that CM5 lead used to detect myocardial ischaemia intraoperatively but do not mention the risk in results. The results relate to BP and rate pressure product changes only.

De Brujin 1987

MethodsRandomized, placebo controlled study, unblinded


Participants40 patients scheduled for elective coronary surgery. Mean age 57-59.2 years across groups


InterventionsGP I - Control

GP II - Esmolol infusion


OutcomesMyocardial Ischaemia


NotesHigh risk patients undergoing coronary bypass


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomized to receive an esmolol infusion or 5% dextrose" mentioned.No details provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskUnblinded study

Quote: "The study was not blinded"

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Denlinger 1974

MethodsRandomized, double blind, placebo controlled study


Participants12 patients for elective cardiac surgery.


InterventionsGP I - Control
GP II - Lidocaine 3% 4 ml (120 mg spray)


OutcomesArrhythmias


NotesHigh risk patients with coronary artery disease


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: ".....were randomly divided into two equal groups " in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "The assignment code was not made known to the investigator"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Durrani 2000

MethodsRandomized, controlled, unblinded


Participants30 ASA 1 and 2 patients. Both males and females, mean age range 42.3-44.7 years


InterventionsGP I - Chloroprocaine 4.5 mg kg-1

GP II - Lignocaine 1.5 mg kg-1

GP III - Placebo


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"Randomization" mentioned in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Ebert 1989

MethodsRandomized, double blind, placebo controlled study


Participants60 ASA 3 and 4 undergoing non-cardiac surgery


InterventionsGP I - Control
GP II - Esmolol 500 ug kg/min for 6 minutes + 300 ug kg/min for 9 minutes
GP III - Fentanyl 0.8 ug kg /min infusion for 10 minutes


OutcomesECG evidence of ischaemia


NotesHigh risk patients, ASA 3 or 4


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly assigned to one of three equal groups" in methodology

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Each drug was packaged in a coded vial with the contents unknown to the observer". Identical infusions were used for the drugs

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo information

Incomplete outcome data (attrition bias)
All outcomes
Low risk60 patients enrolled in trial and data of 60 patients presented in results (Table II of study)

Selective reporting (reporting bias)Unclear riskInsufficient information

Girard 1986

MethodsRandomized, controlled, not blinded


Participants20 Patients undergoing myocardial revascularization. Mean age 59 years across groups


InterventionsGP I - Bolus esmolol followed by infusion

GP II - Control placebo


OutcomesMyocardial ischaemia


NotesPatients undergoing myocardial revascularization. Only phase 11 of study included


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Twenty patients were randomly assigned to an esmolol or placebo group" in methodology

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not mentioned in phase II of study

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Hart 1989

MethodsRandomized, controlled, and unblinded


Participants20 male patients undergoing elective coronary artery bypass grafting with obstruction of more than 75% of one or more major coronary artery


InterventionsGP I - Saline

GP II - Nitroglycerine 1 ug kg-1 min-1


OutcomesMyocardial ischaemia


NotesPatients undergoing elective coronary artery bypass surgery


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "random" mentioned in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Low riskObservation for myocardial ischaemia mentioned as objective

Inada 1989

MethodsRandomized, double blind, placebo controlled study


Participants40 adult ASA 1 to 3 patients. 21-71 years of age. Both males and females


InterventionsGP I - Control
GP II - Lidocaine 100 mg IV
GP III - Labetalol 5 mg IV
GP IV - Labetalol 10 mg IV


OutcomesArrhythmias


NotesHigh risk patients with hypertension and ischaemic heart disease. Drug preparation for this study was supported by funds from Schering Corporation


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Each patient was randomly assigned", mentioned in methodology. No details provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Double blinded study" in introduction and abstract,and identical syringes used for different drugs

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Low risk40 patients entered and data of 40 patients presented in results. Table 2 of study

Selective reporting (reporting bias)Unclear riskInsufficient information

Iyer 1988

MethodsRandomized, controlled, unblinded


Participants80 patients for coronary artery vein graft surgery. Mean age 52-58 years across groups


InterventionsGP I - No drug

GP II - Fentanyl 2 ug kg-1

GP III - Fentanyl 5 ug kg-1

GP IV - Fentanyl 10 ug kg-1

GP V - Fentanyl 15 ug kg-1


OutcomesArrhythmia


NotesPatients undergoing coronary artery bypass grafting


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "They were randomly allocated to one of five groups" in methods. Details not provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients were anaesthetized but no mention of blinding of investigators to the study drug

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High riskThe no drug control group was terminated prematurely because of side effects

Selective reporting (reporting bias)Unclear riskInsufficient information

Jakobsen 1992

MethodsRandomized, double blind controlled study


Participants40 healthy women undergoing elective hysterectomy


InterventionsGP I - Control, placebo tablets 1 to 2.5 hours before surgery
GP II - Metoprolol 100mg tablet


OutcomesArrhythmias


NotesArrhythmias were observed throughout surgery and the authors did not separately mention the frequency of arrhythmias associated with intubation period


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: ".....patients were randomized to receive" in methods. Details not provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: ".....patients were randomized to receive blindly either oral metoprolol or ..." in methods. Details not provided

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Kale 1988

MethodsRandomized, double blind controlled study


Participants30 patients aged 30-60 years of either sex with coronary artery disease undergoing coronary artery bypass grafting


InterventionsGP I - Control (no placebo)
GP II - Nifedipine 10mg sublingual


OutcomesArrhythmias
ECG evidence of ischaemia


NotesHigh risk patients with coronary artery disease


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "They were allocated ......to one of two groups of 15 each with help of a random chart"

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskOne group received study drug SL nifedipine, no placebo given to other group

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Kay1987

MethodsRandomized, placebo controlled, double blind


Participants30 normotensive ASA 1 and 2 patients undergoing elective surgery. Both males and females included


InterventionsGP I - Saline placebo

GP II - Sufentanil 0.5 ug kg-1

GP III - Sufentanil 1.0 ug kg-1


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: ".....were allocated randomly into three groups" in methods. Details not provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Investigation was .....double blinded". Drugs were identical in appearance and prepared by anaesthetist unconnected with the study

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Kaya 2008

MethodsRandomized, placebo controlled, double blind


Participants60 normotensive ASA 1 and 2 patients undergoing elective surgery. Both males and females included. Mean age 42.8-44.3 years


InterventionsGP I - Placebo

GP II - Gabapantene 800 mg


OutcomesArrhythmias and myocardial ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomly assigned using a computer generated table"

Allocation concealment (selection bias)Low riskPharmacy controlled randomization

Quote: "Code number was assigned"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Patients and anaesthetists involved in patient management and data collection were unaware of group assignment"

drugs prepared by pharmacy

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Patients and anaesthetists involved in patient management and data collection were unaware of group assignment"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Kindler 1996

MethodsRandomized, double blind, placebo controlled study


Participants90 ASA 1 and 2 normotensive women scheduled for elective gynaecological procedures. Median age 41 years, range 17-70 years


InterventionsGP I - Lidocaine 1.5 mg/kg
GP II - Esmolol 1 mg/kg
GP III - Esmolol 2 mg/kg
GP VI - Control


OutcomesArrhythmias


NotesGP IV and GP V received combination of lidocaine and esmolol and were not included in the review


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The patients were randomly allocated using computer generated random numbers"

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "A nurse anaesthetist not participating in investigation prepared the study drugs in ready to use syringes so as to ensure that study was double blind"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskIndependent observer recorded variables

Incomplete outcome data (attrition bias)
All outcomes
Low risk90 patients entered the trial and data of 90 patients present in results

Selective reporting (reporting bias)Unclear riskInsufficient information

Ko 1998

MethodsRandomized, controlled, unblinded


Participants155, ASA 1 or 2 patients aged 20-65 years


InterventionsGP I - Control

GP II - Fentanyl 2 ug kg-1 1 minute before intubation

GP III - Fentanyl 2 ug kg-1 3 minute before intubation

GP IV - Fentanyl 2 ug kg-1 5 minute before intubation

GP V - Fentanyl 2 ug kg-1 10 minute before intubation


OutcomesArrhythmias


NotesAdditional 15 patients did not complete the study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "175 patients were randomly assigned to one of five groups" in abstract

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo mention of blinding

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High risk15 patients did not complete the study and were excluded. Their data is not included in analysis

Selective reporting (reporting bias)Low riskObservation for arrhythmia mentioned in methodology

Korpinen 1995a

MethodsRandomized, double blind, placebo controlled study


Participants59 ASA 1 - 2 patients. Mean age 26 years (15-50 years)


InterventionsGP I - Control
GP II - Esmolol 2 mg/kg IV
GP III - Esmolol 3 mg/kg IV
GP IV - Alfentanil 0.03 mg/kg IV


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "randomly allocated" mentioned

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Korpinen 1995b

MethodsRandomized, double blind, placebo controlled study


Participants45 ASA 1 - 2 patients. Mean age 26-32 years


InterventionsGP I - Control
GP II - Esmolol 2 mg/kg IV
GP III - Alfentanil 0.03 mg/kg IV


OutcomesArrhythmias


NotesThree out of four intervention groups included. Study was supported by the Paivikki and Sakari Sohlberg Foundation Helsinki, Finland

The fourth intervention group where 15 patients were given a combination of alfentanil and esmolol were excluded from the review


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly allocated to one of the four groups" in methodology

Allocation concealment (selection bias)Unclear riskNot described

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: " In this double blind study". Details provided

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskDetail not provided

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient reporting

Selective reporting (reporting bias)Unclear riskInsufficient information

Koç 2007

MethodsRandomized, double blind, placebo controlled study


Participants80 Normotensive ASA 1 patients. Mean age 35-25 to 41.1 years across groups


InterventionsGP I - Control
GP II - Gabapentin 800 mg oral
GP III - Dexamethasone 8 mg


OutcomesArrhythmia & ECG evidence of ischaemia


NotesThree out of four intervention groups included (60 patients included)

The fourth intervention group was a combination of dexamethasone and gabapentin


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomly allocated according to computer generated randomization"

Allocation concealment (selection bias)Low riskQuote: "The drugs were prepared by pharmacy and an appropriate code number was assigned"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The study design was randomized and double blind". The study drugs were coded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "In the patient room patients were evaluated for pain scores, heart rate and mean arterial pressure by an anaesthesiology resident not otherwise involved in study."

Incomplete outcome data (attrition bias)
All outcomes
Low risk80 patients were enrolled and data of 80 patients present in results

Selective reporting (reporting bias)Unclear riskInsufficient information

Lee 2011

MethodsRandomized, double blind placebo controlled trial


Participants194 ASA 1 and 2 elective patients undergoing gastric or colorectal surgery


InterventionsGroup 1 - Hydromorphone 0.03 mg kg -1IV

Group II - Fentanyl 2 ug kg -1 IV

Group III - Saline IV


OutcomesST segment changes


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskComputer generated random number in coded envelopes

Allocation concealment (selection bias)Low riskTreatment group allocation concealed from personnel administering drugs

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding with identical syringes

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcome assessor blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskThree patients in fentanyl and one in saline did not complete the study. Intention-to-treat analysis done

Selective reporting (reporting bias)Low riskOutcome predefined in methodology

Lindgren 1987

MethodsRandomized controlled trial


Participants113 adult ASA 1 patients


InterventionsGroup I: Fentanyl 1 µg kg -1 IV

Group II: Fentanyl 2 µg kg -1 IV

Group III: Fentanyl 3 µg kg -1 IV

Control group: No pretreatment


OutcomesVentricular ectopic beats and junctional rhythm


NotesEffect of fentanyl was studied in 113 adults and 77 children. Only data related to adults included

Work on study supported by Paulo Foundation, Helsinki, Finland


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "the patients were randomly allocated to ...". in methods but no detail provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskBlinding not mentioned

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo detail provided

Incomplete outcome data (attrition bias)
All outcomes
Low risk113 adult patients entered in study and results of 113 patients reported

Selective reporting (reporting bias)Low riskMethodology mentions observation for ECG changes

Maekawa 1992

MethodsRandomized, double blind, placebo controlled study


Participants30 ASA 1 normotensive patients. Both male and female patients Mean age 41.1-42.3 across groups (range 27-51 years)


InterventionsGP I - Control
GP II - Nisoldipine 5mg oral
GP III - Nisoldepine 10mg oral


OutcomesArrhythmia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "This randomized....study" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The investigator and patients were blinded to the identity of the experimental treatment."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskFurther measurement were taken "....by independent observer"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Maekawa 1993

MethodsRandomized double blind, placebo controlled study


Participants30 ASA 1 normotensive patient scheduled for elective surgery. Both male and female patients mean age 42.3-43 years (range 25-58 years)


InterventionsGP I - Control
GP II - Nitrendipine 5mg oral
GP III - Nitrendipine 10mg oral


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "They were randomly assigned to one of three groups"

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The investigator and patients were blinded to the identity of the experimental treatment."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: " Further measurements were taken ....by an independent observer"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Magnusson 1986

MethodsRandomized, controlled, unblinded


Participants27 Hypertensive patients both males and females. Mean age 56-57 years across groups


InterventionsGP I - Control

GP II - Metaprolol 15 mg IV pre-induction


OutcomesArrhythmia and myocardial ischaemia


NotesHypertensive patients


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were divided in two groups of fifteen by stratified randomization" mentioned

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo mention of blinding, most likely an unblinded trial

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Mahajan 1993

MethodsRandomized, double blind, placebo controlled study


Participants30 patients , aged 40-60 years of either gender undergoing coronary artery surgery


InterventionsGP I - Nitroglycerine 30 mg topical
GP II - Control


OutcomesArrhythmias
ECG evidence of ischaemia


NotesHigh risk patients with ischaemic heart disease


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly allocated to one of two equal groups" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The study was carried out in a double blind manner". Patients and investigators were blinded

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Maharaj 1983

MethodsRandomized, unblinded, placebo controlled study


Participants60 patients undergoing elective surgery


InterventionsGP I - Saline

GP II - Labetalol 0.25 ug kg-1

GP III - Practolol 0.4 mg kg-1

GP IV - Labetalol 0.5 ug kg-1


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "randomization" mentioned in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskNo mention of blinding

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Mallon 1990

MethodsRandomized, double blind placebo, controlled study


Participants45 ASA I - 3 patients, undergoing elective noncardiac surgery


InterventionsGP I - Control
GP II - Esmolol 100 mg IV
GP III - Esmolol 200 mg IV


OutcomesArrhythmias

Ischaemia


NotesSupported in past from Grant, Dupont Pharmeceutical, Missisaga, Ontario


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Random allocation by computer"

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskMethodology mentions double blinding for drug administration

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Holter tapes were reviewed by a cardiologist to determine the risk of dysrhythmia and ST segment abnormality"

Incomplete outcome data (attrition bias)
All outcomes
Low risk45 patients entered study and data of 45 patients reported in results

Selective reporting (reporting bias)Low riskMethodology mentions observation for both arrhythmia and ECG evidence of ischaemia

Memis 2006

MethodsRandomized, double blind, placebo controlled study


Participants90 ASA 1 and 2 patients undergoing elective surgery. Both male and female patients, mean age 43-47 years


InterventionsGP I - Control
GP II - Gabapentin 400 mg oral
GP III - Gabapentin 800 mg oral


OutcomesArrhythmias

Ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "The study design was randomized.The patients were randomly allocated according to computer generated randomization"

Allocation concealment (selection bias)Low riskQuote: "The study drugs were prepared by pharmacy and an appropriate code number was assigned"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The study design was randomized and double blind". Study drugs were prepared by pharmacy and coded therefore patients were unaware

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High riskQuote: "One patient in placebo group was excluded because of difficult intubation" in results

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1990a

MethodsRandomized, double blind, placebo controlled study


Participants30 normotensive ASA 1 patients. Both males and females. Mean age 45.4-48.9 years across groups


InterventionsGP I - Control
GP II - Diltiazem 0.2 mg/kg IV
GP III - Diltiazem 0.3 mg/kg IV


OutcomesVentricular arrhythmia on ECG


NotesTwo part study, only second part included. Diltiazem provided by Tanabe Pharmaceutical Co. (Osaka, Japan)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were randomly divided into three groups" in methods, but detail not mentioned

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "All intubations were performed by the first author who was unaware of the nature of injections". Patients were anaesthestized and therefore were unaware of nature of injection

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1990b

MethodsRandomized, double blind, placebo controlled study


Participants30 ASA 1 normotensive patients


InterventionsGP I - Control
GP II - Nicardipine 15 ug kg-1
GP III - Nicardipine 30 ug kg-1


OutcomesArrhythmia


NotesTwo part study, only second part included. Grant from Ministry of Education, Japan


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients....were allocated randomly to Group A and Group C" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "All intubations were performed by first author who was unaware of nature of injections". Patients were anaesthetized

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1991a

MethodsRandomized, double blind, placebo controlled study. Exclusion criteria not mentioned


Participants30 ASA I patients. normotensive patients. Mean age 43.5-45.1 years. Both male and female patients


InterventionsGP I - Control
GP II - Pindolol 2 mg/kg IV
GP III - Pindolol 4 mg/kg IV


OutcomesArrhythmias on ECG


NotesTwo phase study, only second part included


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were allocated randomly to three groups" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding mentioned in methodology

Blinding of outcome assessment (detection bias)
All outcomes
Low riskRecording done by independent observer

Quote: "....arterial pressure and heart rate were recorded simultaneously by an independent observer"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskAttrition not mentioned and patient number in each group not mentioned in results

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1991b

MethodsRandomized, double blind, placebo controlled study


Participants30 ASA I normotensive patients. Both males and females. Mean age 45.6-48.1 years


InterventionsGP I - Control
GP II -ATP 0.05 mg kg-1
GP III - ATP 0.1 mg kg -1


OutcomesVentricular arrhythmia on ECG


NotesTwo part study, only second part included. Supported by grants from Ministry of Education, Japan


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were allocated randomly to three groups" in methodology but no details provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskAll intubations were performed by one of the authors who was unaware of the nature of injection

Drugs were administered simultaneously with induction so patients were unaware

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1992a

MethodsRandomized double blind, placebo controlled study


Participants30 normotensive patients. undergoing elective surgery. Both males and females. Mean age 41.1-43.5 years across groups


InterventionsGP I - Control
GP II - Nivaldepine 2mg oral
GP III - Nivaldepine 4mg oral


OutcomesArrhythmia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were randomly divided into three groups" in methods but no detail provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The investigator and the patients were blinded to the identity of the experimental treatments"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskImmediately before induction of anaesthesia MAP and heart rate were recorded simultaneously by the independent observer

Quote: "Further measurements were taken by an independent observer"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1992b

MethodsRandomized, double blind, placebo controlled study


Participants30 normotensive patients for elective surgery. Both male and female patients. Mean age 40.9-43.3 years across groups


InterventionsGP I - Control
GP II - Nitroglycerine 1.5 ug kg-1 IV
GP III - Nitroglycerine 2.5 ug kg-1 IV


OutcomesArrhythmia


NotesTwo part study, only part two included


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were randomly divided into three groups" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskAll intubations were performed by the first author who was blinded to the injection

Patients were anaesthetized when the drugs were administered

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Low risk30 patients entered the study and data of 30 patients presented in results

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1993

MethodsRandomized, double blind, placebo controlled study


Participants30 ASA 1 Normotensive patients scheduled for elective surgery. Both males and females included. Mean age varied from 40.3-42.2 across groups


InterventionsGP I - Control
GP II - Guanabenz 4 mg oral
GP III - Guanabenz 6 mg oral


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "They were randomly assigned to one of three groups" in methodology

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskThe investigator and the patient were blinded to the nature of experimental treatment

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Measurements were taken at ....minutes by an independent observer"

Incomplete outcome data (attrition bias)
All outcomes
Low risk30 patients were enrolled in the study and data of 30 patients is presented in results

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1994

MethodsRandomized double blind, placebo controlled study


Participants30 ASA I normotensive patients scheduled for elective surgery both males and females. Mean age range 41.9-43.4 years (range 27-51 years)


InterventionsGP I - Control
GP III - Manidipine 5 mg
GP III - Manidipine 10mg


OutcomesArrhythmia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "They were randomly assigned to one of three groups" in methodology

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The investigator and the patient was blinded to the nature of experimental treatment."

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Further measurements were taken ........by an independent observer"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Mikawa 1996

MethodsRandomized double blind, placebo controlled study


Participants60 ASA I normotensive patients. Both males and females. Mean age range 43-47 years


InterventionsGP I - Control
GP II - Nicardipine 30 ug kg-1 IV
GP III - Diltiazem 0.2 mg kg -1 IV
GP IV - Verapamil 0.1 mg kg-1 IV


OutcomesArrhythmias
Intraoperative and postoperative morbidity


NotesWritten to author, response awaited


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "They were allocated randomly to one of four groups" in methodology, but details not mentioned

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "A double dummy technique was used to maintain a double blind design". All patients received two injections

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: " Immediately before induction of anaesthesia .....SAP, DAP and heart rate were recorded simultaneously by independent observers"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Miller 1991

MethodsRandomized, multicentre, placebo control trial


Participants548, 18 years and above for elective non-cardiac surgery


InterventionsGroup I - Placebo

Group II - Esmolol IV 100 mg

Group III - Esmolol IV 200 mg


OutcomesMortality


NotesMulticentre trial conducted in 12 university affiliated centres across Canada. Narcotics were used in five of the participating centres. In six centres patients had history of cardiac disease or two or more coronary artery disease risk factors.In three of the centres patients were on beta blockers.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote "each patient received the study medication or placebo according to random assignment in blocks of 45 for each centre into one of the following treatment groups"

Allocation concealment (selection bias)Low riskQuote "at each centre the medication was distributed by the hospital pharmacy in coded labelled vials in order to prevent group identification by the investigator"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote "at each centre the medication was distributed by the hospital pharmacy in coded labelled vials in order to prevent group identification by the investigator". Also double blinding mentioned as trial design

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNot mentioned

Incomplete outcome data (attrition bias)
All outcomes
Low riskAll 548 patients completed the study

Selective reporting (reporting bias)High riskMortality mentioned in the results but not mentioned in the objectives

Montazeri 2011

MethodsRandomized double blind clinical trial


Participants96 ASA 1 and 2 patients, 18 to 65 years


InterventionsGroup 1 - Placebo oral

Group II - Gabapentin 800 mg oral

Group III - Clonidine 0.3 mg oral


OutcomesArrhythmia and ST segment changes


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskRandom allocation mentioned, code number assigned

Allocation concealment (selection bias)Low riskInvestigator obtaining consent was blind to randomization

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBlinded observer collected data

Incomplete outcome data (attrition bias)
All outcomes
High risk12 dropouts

Selective reporting (reporting bias)Unclear riskInsufficient information

Newsome 1986

MethodsRandomized, controlled, double blind


Participants30 patients with good left ventricular function (ejection fraction > 45) undergoing elective aortocoronary bypass surgery, mean age 54-57 years across groups


InterventionsGP I - No therapy

GP II - Esmolol 500 ug for 2 minutes

GP III - Placebo


OutcomesMyocardial ischaemia


NotesPatients undergoing aortocoronary bypass


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomized to receive either esmolol or placebo" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "This part of the study was double blinded" in methods. Patient received comparable volumes under blinded conditions

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information regarding attrition

Selective reporting (reporting bias)Unclear riskInsufficient information

Oxorn 1990

MethodsRandomized, double blind, placebo controlled study


Participants48 ASA 1 and 2 patients above 18 years of age. Females undergoing vaginal hysterectomy


InterventionsGP I - Control
GP II - Esmolol 100 mg IV
GP III - Esmolol 200 mg IV


OutcomesArrhythmias
ECG evidence of ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "48 patients were equally randomized by hospital pharmacist to one of the three groups"

Allocation concealment (selection bias)Low riskCentral allocation by pharmacist

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding done for drug administration

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "This was done by a cardiologist who was blinded to the patient groups"

Incomplete outcome data (attrition bias)
All outcomes
Low risk48 patients entered study and data of 48 patients presented in results

Selective reporting (reporting bias)Unclear riskInsufficient information

Pouttu 1988

MethodsRandomized, double blind, placebo controlled study


Participants44 ASA I patients scheduled for elective surgery Both males and females, mean age 31-34 years across groups


InterventionsGP I - Lidocaine 1 mg/kg IV
GP II - Control


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "......randomly and in a double blind fashion" in methods but no details provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "....and in a double blind fashion" in methods in reference to drugs administered

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Puri 1986

MethodsRandomized, double blind, placebo controlled study


Participants35 normotensive patients, age 15-50 years undergoing elective surgery


InterventionsGP I - Control
GP II - Verapamil 0.1 mg/kg IV


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "randomly" mentioned in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskThe investigators did not know which solution was which. However, one group of patients did not receive a placebo whereas other group was administered verapamil

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Puri 1998

MethodsRandomized, double blind, placebo controlled study


Participants36 patients with coronary artery disease. Mean age 51.2-54.9 years


InterventionsGP I - MgSO4 50 mg/kg IV
GP II - Placebo


OutcomesArrhythmias

ECG ischaemia


NotesHigh risk patients with coronary artery disease. 3 patients from each group excluded on analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly assigned to receive......" in methods

Allocation concealment (selection bias)Low riskQuote: "Persons allocating and preparing the drugs were not involved in administering it or in observations of cardiovascular responses"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Persons allocating and preparing the drugs were not involved in administering it or in observations of cardiovascular responses"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "Persons allocating and preparing the drugs were not involved in administering it or in observations of cardiovascular responses"

Incomplete outcome data (attrition bias)
All outcomes
High riskSix patients withdrawn

Selective reporting (reporting bias)High riskBoth arrhythmias and ST segment observation mentioned in methodology, but result relating to arrhythmias was not mentioned in results

Quere 1990

MethodsDouble blinded, randomized study


Participants50 ASA I and II patients undergoing abdominal and vascular surgery included


InterventionsGroup I: Urapidil 0.4 mg kg -1 IV

Group II: Placebo


OutcomesCardiac arrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "This randomized study....". No further details available

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "This double blind study .." mentioned in study design

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Ryhanen 1977

MethodsControlled trial


Participants39 patients of varying ages


InterventionsGP I - Healthy patients not given practolol

GP II - Healthy patients given practolol 0.2mg kg -1 IV

GP III - Patients with CVS disease not given practolol

GP IV- Patients with CVS disease given practolol 0.2mg kg -1 IV


OutcomesFrequency of new arrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Low risk39 patients entered the study, the results shows 39 patients indicating no dropouts

Selective reporting (reporting bias)Unclear riskInsufficient information

Scheinin 1989

MethodsRandomized, double blind, placebo controlled study


Participants20 healthy ASA 1 patients for elective surgery. Both males and females included. Mean age 40-44 years across groups


InterventionsGP I - Alfentanil 75 ug kg-1 IV
GP II - Control


OutcomesArrhythmias


NotesStudy supported by grant from Finska Lakaresallskapet, Finland


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The patients were allocated randomly to receive either alfentanil or saline" in methods. No further details provided

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskPatients and investigators were unaware of drug given as coded identical syringes used

Blinding of outcome assessment (detection bias)
All outcomes
Low riskCode was not broken until study was complete

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Sharma 1995

MethodsRandomized, placebo controlled, unblinded study


Participants73 ASA 1 and 2, 49 males and 34 females undergoing elective noncardiac surgery. Mean age 35-39 years across groups


InterventionsGP I - Placebo

GP II - Esmolol 100 mg bolus

GP III - Esmolol 200 mg bolus


OutcomesArrhythmia and myocardial ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly allocated to receive placebo,100 mg or 200 mg of esmolol..." mentioned in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskDouble blinding mentioned in abstract and introduction

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High riskTwo patients withdrawn from study

Selective reporting (reporting bias)Unclear riskInsufficient information

Singh 1995

MethodsRandomized, double blind, placebo controlled study


Participants40 ASA 1 and 2 adult males undergoing elective surgery, mean age 48-56 across groups


InterventionsGP I - Control
GP II - Lignocaine 1.5 mg kg-1 IV
GP III - Esmolol 1.4 mg kg-1 IV
GP IV - Nitroglycerine 2 ug-1kg IV


OutcomesArrhythmias
ECG evidence of ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "....were randomized by computer generated table"

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: ".....according to a double blind placebo controlled protocol" in methodology

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk40 patients enrolled in study but attrition not mentioned

Selective reporting (reporting bias)Unclear riskInsufficient information

Sklar 1992

MethodsRandomized, double blind, placebo controlled study


Participants80 ASA 1 and 2 patients. 25-40 years without known heart disease or hypertension and schedules for major abdominal surgery


InterventionsGP I - Lidocaine 40 mg inhalation
GP II - Control


OutcomesArrhythmias


NotesTwo stage study, only part one of the study included. Second part quasi-randomized


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "randomly assigned 40 patients were ..." in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The solutions were prepared in a double blind manner"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "and the observer of the results were unaware of the drug used"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Song 1997

MethodsRandomized, double blind, placebo controlled study


Participants106 ASA 1 and 2 normotensive adult patients, undergoing elective surgery . Both males and females included. Mean age range 43-49 years across groups


InterventionsGP I - Control
GP II - Nicardipine 0.5 mg IV
GP III - Nicardipine 1 mg IV
GP IV - Nicardipine 2 mg IV
GP V - Nicardipine 4 mg IV


OutcomesECG evidence of ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were assigned to one of the five treatment regimens according to a computer generated random number table."

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: "We designed a randomized double blind ....study". No further details available

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High riskSix patients were excluded due to difficult intubation their data was not included in analysis

Selective reporting (reporting bias)Unclear riskInsufficient information

Splinter 1989

MethodsRandomized, controlled, unblinded study


Participants150 ASA 1 to 3 patients, age range 65-92 years


InterventionsGP I - Placebo

GP II - Lignocaine

GP III - Fentanyl 1.5 ug kg-1

GP IV - Fentanyl 3 ug kg-1


OutcomesArrhythmias and myocardial ischaemia


Notes101 patients included in this review. Two groups that used a combination of lignocaine and fentanyl excluded from analysis


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "random" mentioned in methodology. No details available

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskInsufficient information. Double blinding not mentioned

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Stone 1988

MethodsNon double blind, randomized prospective study


Participants128 uncontrolled hypertensive patients


InterventionsGP I -Control group, no pretreatment (n=39)

GP II - Single oral tablet of labetalol (n=29)

GP III - Single oral tablet of atenolol 50 mg (n=30)

GP 4 - Single oral tablet of oxyprenolol (n=30)


OutcomesMyocardial ischaemia


NotesHigh risk patients with uncontrolled hypertension studied. Anaesthetic technique not standardized and several methodological flaws in the study which could bias results. Variable induction agents and narcotic agents used,Induction recordings also included early surgical period.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskWord "randomly allocated" mentioned in methodology. No details available

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
High riskAnaesthetists were not blinded to their patient's medication

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "The electrographic recordings were subsequently interpreted by a cardiologist who was blinded to the patient's treatment"

Incomplete outcome data (attrition bias)
All outcomes
Low risk128 patients enrolled in the study and the results of 128 patients given in the result section

Selective reporting (reporting bias)Low riskObservation for ischaemic changes was documented in methodology

Sun 2009

MethodsRandomized, controlled, double blind study


Participants56 ASA 1 and 2 adult patients scheduled for elective surgery aged 20-60 years


InterventionsGP I - Normal saline

GP II - Lignocaine 5 ml 2% Inhaler


OutcomesArrhythmia and ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Patients were randomly allocated" using computer generated codes

Allocation concealment (selection bias)Low riskQuote: "The assignments were kept in a sealed sequentially numbered envelopes until used.Neither patients nor investigators were aware of the treatment allocation"

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "The syringes for both groups were prepared by a third party immediately before use and were visibly indistinguishable to the investigator"

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: "No patients were withdrawn from data analysis"

Selective reporting (reporting bias)Low riskObservation for arrhythmia and ischaemic changes was documented in methodology

Thomson 1984

MethodsRandomized, controlled, double blind study


Participants20 patients undergoing elective CABG surgery. Mean age 54.4-56.2 years across groups


InterventionsGP I - Nitroglycerine 0.5 ug kg-1 min-1

GP II - Placebo


OutcomesMyocardial ischaemia


NotesPatients with ischaemic heart disease


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Twenty patients.....and randomly assigned to one of two groups" in methodology

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: "A double blinded protocol was followed". No details provided

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "The representative ECG strips were .......coded. Another investigator than evaluated each ECG"

Incomplete outcome data (attrition bias)
All outcomes
Low risk20 patients entered the trial and results of 20 presented (see Table 5 in study)

Selective reporting (reporting bias)Low riskRisk of myocardial ischaemia mentioned as an objective

Victory 1995

MethodsRandomized, controlled, unblinded study


Participants40 ASA 1 and 2 patients for minor surgical procedures (orthopaedic and general surgery). Both males and females, mean age 36-38 years


InterventionsGP I - Saline

GP II - Bupivacaine 0.75% nebulized


OutcomesArrhythmias


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Computer generated series of random numbers"

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskInsufficient information

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient information

Selective reporting (reporting bias)Unclear riskInsufficient information

Wang 2003

MethodsRandomized, double blind, placebo controlled study


Participants135 ASA 1 patients aged 20-35 years. Mean age 32.1-36.6 years across groups


InterventionsGP I - Control
GP II - Lidocaine 2 mg/kg 1 minute before intubation
GP III - Lidocaine 2 mg/kg 3 minute before intubation
GP IV - Lidocaine 2 mg/kg 5 minute before intubation
GP V - Lidocaine 2 mg/kg 10 minute before intubation


OutcomesArrhythmias


NotesAll intervention groups were considered one as they all used the same dose

10 patients did not complete the protocol


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly divided" in methods

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: ".....were admitted to this double blinded study" but no details given

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
High risk10 patients did not complete the study and were excluded. Their data is not presented

Selective reporting (reporting bias)Low riskAuthors mention observing for arrhythmias in their methodology

White 2003

MethodsRandomized, double blind, placebo controlled study


Participants30 ASA 1 and 2 patients. Females undergoing gynaecological procedures, mean age 35 and 11 (gp I) and 41 and 11 (gp II)


InterventionsGP I - Control
GP II - Esmolol 50 mg IV bolus + infusion


OutcomesArrhythmias


NotesTwo out of three intervention groups included

the third group was a combination of esmolol and nicardipine


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Randomly assigned" in methods. No details

Allocation concealment (selection bias)Unclear riskNot described

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "Double blinded placebo controlled protocol"

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Low risk45 patients entered study and data of 45 presented

Selective reporting (reporting bias)Unclear riskInsufficient information

Zargar 2002

MethodsRandomized, controlled, double blind study


Participants60 ASA 2 patients 30-65 years of age of either sex


InterventionsGP I - Control

GP II - Metoprolol 4 mg

GP III - Esmolol 25 mg


OutcomesArrhythmia and ischaemia


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients were randomly allocated to one of the three groups" in methodology

Allocation concealment (selection bias)Unclear riskInsufficient information

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: "a .....double blind study" and "decoding at end of study" mentioned in summary

Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskInsufficient information

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskInsufficient reporting

Selective reporting (reporting bias)Unclear riskInsufficient information

 
Characteristics of studies awaiting assessment [ordered by study ID]
Adams 1987

MethodsControlled study

Participants40 patients undergoing orthopaedic surgery

InterventionsTopical lidocaine one or two step method

OutcomesArrhythmia

NotesAbstract available which mentions that authors observed myocardial ischaemia. Full text with detail of results not available. German language paper

Ay 1999

MethodsControlled trial

Participants28 ASA 2 and 3 patients with coronary artery disease, 40 to 80 years of age

InterventionsGp 1: 15 µg kg-1 alfentanil IV

Gp II: 0.2 mg kg-1 diltiazem

Gp III: Control no medication

OutcomesMyocardial ischaemia

NotesOnly abstract in English available. Full text with detail of results not available. Turkish language paper

Bhawna 2012

Methods

Participants

Interventions

Outcomes

NotesStudy identified in the second search (2011 to 2012)

Cao 1995

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Circulatory responses to endotracheal intubation mentioned in title. Study in Chinese language

Chao 1990

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Circulatory responses to endotracheal intubation mentioned in title. Study in Chinese language

Do 2012

Methods

Participants

Interventions

Outcomes

NotesStudy identified in the second search (2011 to 2012)

Eerola 1971

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. ECG changes on induction mentioned in title

El-Tahan 2012

Methods

Participants

Interventions

Outcomes

NotesStudy identified in the second search (2011 to 2012)

Fujii 1995

MethodsRandomized, controlled, unblinded

Participants37 ASA 2 hypertensive patients, aged 32-74 years. Both males and females

InterventionsGP I - Control

GP II - Nicardipine 30 ug IV

GP III - Diltiazem 0.3 mg kg-1

OutcomesArryhythmia and myocardial ischaemia

NotesStudy on hypertensive patients. Study is available but the author is being interrogated by his university for intellectual dishonesty.

Gupta 2011

Methods

Participants

Interventions

Outcomes

NotesStudy identified in the second search (2011 to 2012)

Heinrichs 1989

MethodsControlled trial

Participants140 female patients, ASA 1 and 2

InterventionsGroup 1: Saline, Group 2: 0.1 mg fentanyl IV, Group 3: 0.2 mg fentanyl IV, Group 4: 0.3 mg fentanyl IV, Group 5: 1 mg of nifedipine

OutcomesArrhythmias

NotesFull text not available only abstract available. Article in German

Hoda 2011

Methods

Participants

Interventions

Outcomes

NotesStudy identified in the second search (2011 to 2012)

Hu 1990

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Cardiovascular responses to tracheal intubation mentioned in title. Study in Chinese language

Hu 1993

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Preventing cardiovascular effects to tracheal intubation mentioned in title. Study in Chinese language

Ishikawa 2012

Methods

Participants

Interventions

Outcomes

NotesStudy identified in the second search (2011 to 2012)

Pan 1997

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Haemodynamic responses to tracheal intubation mentioned in title. Study in Chinese language

Perez 1991

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Haemodynamic consequences of responses to tracheal intubation mentioned in title. Study in Spanish language

Roelofse 1987

MethodsControlled trial

Participants80 patients undergoing oral surgical procedure

InterventionsGroup 1: Labetalol 1mg kg-1 IV

Group 2: Acebutalol 0.25 mg kg-1

Group 3: Lidocaine 2 mg kg-1

Group 4: Saline

OutcomesHaemodynamic response

NotesFull text not available only abstract available

Sulaiman 2012

Methods

Participants

Interventions

Outcomes

NotesStudy identified in the second search (2011 to 2012)

Tang 1995

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Haemodynamic responses to tracheal intubation mentioned in title. Study in Chinese language

Wang 1995

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Stress responses to tracheal intubation mentioned in title. Study in Chinese language

Xu 1994

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Cardiovascular responses to tracheal intubation mentioned in title. Study in Chinese language

Ye 1993

MethodsControlled trial

Participants30 normotensive patients ASA 1 and 2

InterventionsGroup 1: Control

Group 2: Urapidil 0.4 mg kg-1

Group 3: Urapidil 0.6 mg kg-1

OutcomesBlood pressure

NotesFull text not available only abstract available

Zhang 1992

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Circulatory responses to tracheal intubation mentioned in title. Study in Chinese language

Zhao 1994

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Cardiovascular reaction to tracheal intubation mentioned in title. Study in Chinese language

Zhao 1996

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Stress responses to tracheal intubation mentioned in title. Study in Chinese language

Zhao 1998

Methods

Participants

Interventions

Outcomes

NotesNo abstract or full text available. Haemodynamic responses to tracheal intubation mentioned in title. Study in Chinese language

Zsigmond 1988

Methods

Participants40 ASA class 1 and 2 patients

InterventionsGroup 1: Dextose water

Group 2: Emotol 500 µg kg-1 min-1 x 1min + 100 x 10min

Emotol 500 µg kg-1 min-1 x 2min + 200 x 10min

Emotol 500 µg kg-1 min-1 x 4min + 300 x 10min

OutcomesArrhythmia

NotesFull text not available only abstract available

 
Comparison 1. Arrhythmias

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Arrhythmias - by drug type582932Peto Odds Ratio (Peto, Fixed, 95% CI)0.19 [0.14, 0.26]

    1.1 Local anaesthetics
13550Peto Odds Ratio (Peto, Fixed, 95% CI)0.34 [0.18, 0.62]

    1.2 Calcium channel blockers
11381Peto Odds Ratio (Peto, Fixed, 95% CI)0.13 [0.04, 0.41]

    1.3 Sympathetic blockers
18742Peto Odds Ratio (Peto, Fixed, 95% CI)0.22 [0.12, 0.41]

    1.4 Centrally acting alpha agonists
3108Peto Odds Ratio (Peto, Fixed, 95% CI)0.05 [0.00, 3.18]

    1.5 Peripheral vasodilators
373Peto Odds Ratio (Peto, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.6 Narcotics
12620Peto Odds Ratio (Peto, Fixed, 95% CI)0.12 [0.07, 0.21]

    1.7 Miscellaneous
8458Peto Odds Ratio (Peto, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Arrhythmias - sympathetic blockers18742Peto Odds Ratio (Peto, Fixed, 95% CI)0.22 [0.12, 0.41]

    2.1 Beta blockers
14589Peto Odds Ratio (Peto, Fixed, 95% CI)0.23 [0.12, 0.44]

    2.2 Combined alpha and beta blockers
4103Peto Odds Ratio (Peto, Fixed, 95% CI)0.13 [0.01, 1.17]

    2.3 Alpha blockers
150Peto Odds Ratio (Peto, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Arrhythmias - high risk vs low risk patients582866Peto Odds Ratio (Peto, Fixed, 95% CI)0.20 [0.14, 0.27]

    3.1 High risk patients
9337Peto Odds Ratio (Peto, Fixed, 95% CI)0.18 [0.05, 0.59]

    3.2 Low risk patients
492529Peto Odds Ratio (Peto, Fixed, 95% CI)0.20 [0.14, 0.28]

 
Comparison 2. ECG evidence of myocardial ischaemia

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Myocardial ischaemia - by drug type29Odds Ratio (M-H, Fixed, 95% CI)Subtotals only

    1.1 Local anaesthetics
4192Odds Ratio (M-H, Fixed, 95% CI)0.03 [0.00, 0.59]

    1.2 Calcium channel blockers
2130Odds Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 Sympathetic blockers
11459Odds Ratio (M-H, Fixed, 95% CI)0.69 [0.25, 1.88]

    1.4 Peripheral vasodilators
483Odds Ratio (M-H, Fixed, 95% CI)1.5 [0.26, 8.82]

    1.5 Centrally acting alpha agonists
148Odds Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.6 Narcotics
6366Odds Ratio (M-H, Fixed, 95% CI)0.31 [0.01, 8.31]

    1.7 Miscellaneous
6338Odds Ratio (M-H, Fixed, 95% CI)0.10 [0.00, 2.12]

 2 Myocardial ischaemia - high risk vs low risk patients291616Peto Odds Ratio (Peto, Fixed, 95% CI)0.36 [0.16, 0.80]

    2.1 High risk patients
12395Peto Odds Ratio (Peto, Fixed, 95% CI)0.67 [0.27, 1.67]

    2.2 Low risk patients
171221Peto Odds Ratio (Peto, Fixed, 95% CI)0.03 [0.01, 0.18]

 
Comparison 3. Adverse effects

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Local anaesthetics3227Peto Odds Ratio (Peto, Fixed, 95% CI)12.27 [4.03, 37.36]

 2 Beta blockers5259Peto Odds Ratio (Peto, Fixed, 95% CI)24.17 [8.88, 65.79]

 3 Combined alpha and beta blockers246Peto Odds Ratio (Peto, Fixed, 95% CI)6.43 [0.81, 50.98]

 4 Narcotics4218Peto Odds Ratio (Peto, Fixed, 95% CI)149.55 [35.07, 637.65]

 5 Miscellaneous280Peto Odds Ratio (Peto, Fixed, 95% CI)7.46 [0.99, 56.05]

 
Summary of findings for the main comparison.

Pharmacological agents compared with placebo or no treatment for attenuating the haemodynamic response to tracheal intubation

Patient or population: Adult patients 18 years and above undergoing elective surgery

Settings: Operating room

Intervention: Pharmacological agents given for the specific purpose of attenuating the haemodynamic response to tracheal intubation

Comparison: Control group receiving placebo or no treatment

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Control groupPharmacological agents

Arrhythmias - by drug type in all patientsStudy population0.19

(0.14 to 0.27)
2902
(57)
⊕⊕⊕⊝
Moderate1
·  .

133 per 100028 per 1000
(21 to 40)

Arrhythmias - high risk patientsStudy population0.18

(0.05 to 0.59)
337
(9)
⊕⊕⊕⊝
Moderate2
· 

80 per 100015 per 1000
(4 to 49)

Myocardial Ischaemia - by drug type in all patientsStudy population0.36

(0.16 to 0.8)
1636
(30)
⊕⊕⊝⊝
Low3
· 

34 per 100013 per 1000

(6 to 28)

Myocardial Ischaemia - high risk patientsStudy population0.67

(0.27 to 1.67)
395
(12)
⊕⊕⊕⊝
Moderate4
·  

78 per 100053 per 1000

(22 to 123)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk Ratio; [other abbreviations, e.g.. OR, etc]

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 143 of the studies were blinded.All studies mentioned randomization but details were only provided by eight; 13 studies described allocation concealment
2Six studies out of nine with high risk patients were blinded
3Eight studies were blinded.In nine studies details of randomization were mentioned; 12 had allocation concealment and five studies had withdrawals
4Six studies out of 12 with high risk patients were blinded