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Local versus general anaesthesia for carotid endarterectomy

  1. Tanat Vaniyapong1,
  2. Wilaiwan Chongruksut1,
  3. Kittipan Rerkasem1,2,*

Editorial Group: Cochrane Stroke Group

Published Online: 19 DEC 2013

Assessed as up-to-date: 30 SEP 2013

DOI: 10.1002/14651858.CD000126.pub4


How to Cite

Vaniyapong T, Chongruksut W, Rerkasem K. Local versus general anaesthesia for carotid endarterectomy. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD000126. DOI: 10.1002/14651858.CD000126.pub4.

Author Information

  1. 1

    Chiang Mai University, Department of Surgery, Faculty of Medicine, Chiang Mai, Thailand

  2. 2

    Chiang Mai University, Center for Applied Science, Research Institute of Health Sciences, Chiang Mai, Thailand

*Kittipan Rerkasem, Department of Surgery, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand. rerkase@gmail.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 19 DEC 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Binder 1999

MethodsRCT
Block randomisation
Blinding: unclear
C: unclear
Cross-over: yes, but number excluded during trial was unclear
Losses to FU: none


ParticipantsAustria 1999
46 patients (46 operations)
Age mean: 73 years (LA), 68 years (GA)
Sex: unclear
Comparability: unclear
Indications for surgery: TIA, stroke, incidental diagnosis of carotid stenosis


InterventionsLA: superficial and deep block with bupivacaine
GA: thiopental, vecuronium, fentanyl
Patching: all cases
Antiplatelet Rx: unclear
Indication for shunting: all patients


OutcomesDeath, any stroke, TIA, myocardial infarction, time in hospital since surgery, bleeding, mean arterial blood pressure, shunted arteries


NotesFU: 48 hours
Ex: recent neurological deficit < 4 weeks, redo operation, recent myocardial infarction(< 2 months), ASA score ≥ 4, and any factor precluding randomisation such as pulmonary disease or refusal to participate in the study


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "46 Patienten nach Aufklarung and Unterzeichnung einer Einverstandniserklarung in die Studie aufgenommen und prospektiv randomisiert untersucht"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported

Selective reporting (reporting bias)Low riskAll the study's prespecified outcomes of interest were reported

Other biasHigh riskNot reported

Forssell 1989

MethodsRCT
C: unclear
Blinding: unclear
Sequentially numbered envelope
Cross-overs: 8 LA performed under exclusions during trial: 8 cross-overs
Losses to FU: none


ParticipantsSweden 1985 to 1987
100 patients, 111 operations
Age (mean): 66 years (LA), 63 years (GA)
Male: 71% (LA), 64% (GA)
Comparability: groups similar for vascular risk factors
Indication for surgery: not reported


InterventionsLA: cervical block and skin infiltration with bupivacaine and mepivacaine or adrenaline
GA: thiopental, isoflurane and bupivacaine or adrenaline skin infiltration
Patching: not reported
Antiplatelet Rx: not reported
Indication for shunting: LA: neurological symptoms during/or after 1 minute test clamp; GA: stump pressure < 25 mmHg in TIA, stump pressure < 50 mmHg in vertebrobasilar insufficiency, always if previous stroke


OutcomesDeath, any stroke, myocardial infarction, wound haematoma, blood pressure, shunted arteries


NotesFU: hospital stay
Ex: consent refused, allergy to LA, ongoing heparin infusion, serious chronic cerebral insufficiency, uneasy during previous LA, randomisation miss, anxiety, simultaneous aortic repair, emergent operation


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "The remaining patients were randomised on 111 occasions into two groups, which were comparable (Table 2)"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported

Selective reporting (reporting bias)High riskNo prespecified outcomes were reported.

Other biasHigh riskNot reported

GALA 2008

MethodsRCT
C: central trial office allocate and concealment
Blinding: single blinding - independent assessor
Block randomisation
Cross-overs: 92/1751 (5.3%) GA patients and 75/1771 (4.2%) LA patients went to theatre, but received the opposite treatment allocation to that allocated at randomisation
Losses to FU: 3/3523 (0.09%)


ParticipantsMulticentre RCT conducted mainly in Europe (95 centres), in 24 countries 2003 to 2008
3526 operations
Age (mean): 69 years (LA), 70 years (GA)
Male: 71% (LA), 70% (GA)
Comparability: groups similar for vascular risk factors
Indication for surgery: all patients with symptomatic or asymptomatic carotid stenosis for whom surgery was advised

The reasons for using shunt varied in both the LA and GA groups depending on the practice of each trial site

These reasons included: used routinely, drop velocity on TCD, unable to use TCD, contralateral occlusion or near occlusion, low stump pressure, contralateral carotid stenosis, recent stroke, unusual or damaged vein or arteries in head or neck, EEG or evoked potential change, blood pressure drop, falling brain oxygen level, operation converted to vein bypass and unknown


InterventionsLA versus GA


OutcomesPrimary outcome: proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery
Secondary outcomes: proportion alive and stroke free at 1 year and in the longer term, a comparison of health-related quality of life at 30 days and any surgical adverse events, re-operation and re-admission rates, the relative cost of the 2 methods of anaesthesia, length of stay and intensive and high dependency bed occupancy


NotesFU: perioperative period (30 days after operation) and 1 year follow up
Ex: a simultaneous bilateral carotid endarterectomy or carotid endarterectomy combined with another operative procedure such as coronary artery bypass surgery


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskCentral computerised randomisation

Allocation concealment (selection bias)Low riskQuote: "the office randomised patients to surgery under either general or local anaesthesia, stratified by centre and with balanced blocks of variable size, ensuring that allocation was completely concealed before the decision to randomise a patient and after baseline data were received"

Blinding of participants and personnel (performance bias)
All outcomes
High riskQuote: "we could not blind patients or the surgical team to randomised treatment allocation"

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "However, the independent stroke physician or neurologist who saw patients 1 month after surgery was unaware of the type of anaesthesia that the patients had received, although this blinding could be broken by the patient or by looking at hospital notes"

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote in Figure 1: "21 incomplete follow-up, 1 no follow-up at all, 1 no post-surgery form, 19 no physician follow-up at one month five of these had patient follow-up at 1 year"

Selective reporting (reporting bias)Low riskAll data were analysed and reported as predefined

Other biasLow riskMeasurement bias:
Quote: "a neurologist (CPW), unaware of treatment allocation, then prepared a summary for every patient that, depending on the outcome, was audited by an independent neurologist (PMR) or cardiologist (APB), who were also unaware of treatment allocation"

Quote: "Data were analysed by the trial statistician (SCI) and reviewed annually in strict confidence by the Data Monitoring Committee. Everyone else involved in the study was unaware of the treatment allocation until the database was locked"

Funding bias:
Quote: "The funding source had no role in the study design, data collection, data analysis, data interpretation or writing of the report"

Gimenez 2004

MethodsRCT
C: unclear
Blinding: unclear
Cross-over: unclear
Exclusion during trial: unclear
Losses to FU: unclear


ParticipantsSpain 1999 to 2001
93 patients and 93 operations
Age: not indicated
Male proportion: unclear
Comparability: not reported
Indication for surgery: not reported


InterventionsLA: not reported
GA: not reported
Patching and antiplatelet Rx: not reported
Indication for shunting: reported


OutcomesBlood pressure


NotesFU: probably hospital discharge
Ex: not reported
Data were extracted only from abstract and we could not contact the authors of this publication


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "In a prospective randomised study between 1999 and 2001, 93 patients underwent carotid endarterectomy, 47 under GA and 46 under LRA"

Allocation concealment (selection bias)High riskNot reported (only abstract available)

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported (only abstract available)

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported (only abstract available)

Selective reporting (reporting bias)High riskNo prespecified outcomes were reported

Other biasHigh riskNot reported (only abstract available)

Kasprzak 2006

MethodsRCT
C: unclear
Blinding: independent neurologist
Cross-over: 6 patients change from LA to GA
Exclusion during trial: none
Losses to FU: none


ParticipantsGermany 2006
186 patients,186 operations
Age (mean): 69 years (LA), 69 years (GA)
Male: 67% (LA), 61% (GA)
Comparability: group similar for vascular risk factors
Indication for surgery: asymptomatic carotid stenosis > 80% or symptomatic carotid stenosis > 70%


InterventionsLA: superficial and deep cervical plexus block by 0.5% bupivacaine + 1% prilocaine
GA: fentanyl, etomidate, vecuronium, isoflurane
Patching and antiplatelet: not reported
Indication for shunting: LA: motor deficit, aphasia and loss of consciousness during carotid artery clamping; GA: decrease > 30% of amplitude in the baseline somatosensory evoked potential


OutcomesDeath, stroke, myocardial infarction, cranial nerve injury, blood pressure, shunting


NotesFU: possibly hospital stay
Ex: not meeting inclusion criteria, refused to participate, recalled consent, temporarily not operable, pilot study and other reason


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "randomized by computer random list for one type of anesthesia"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
Low riskQuote: "a neurological evaluation by a neurologist and a routine postoperative CT scan were done on day b2 or 3 after surgery. The neurologist was not informed about the type of anesthesia"

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote in Figure 1: "received allocated treatment n = 95 analysed n = 95"

Selective reporting (reporting bias)Low riskAll the study's prespecified outcomes of interest were reported

Other biasHigh riskNot reported

Luchetti 2008

MethodsRCT
C: unclear
Blinding: unclear
Cross-over: unclear
Exclusion during trial: unclear
Losses to FU: unclear


ParticipantsItaly 2008
28 patients, 28 operations
Age/male: unclear, but publication indicated that demographic data and baseline haemodynamic values are comparable
Indication for surgery: unclear


InterventionsLA: superficial cervical plexus block by 0.5% ropivacaine 30 cc
GA: superficial cervical plexus block with continuous infusion of remifentanil, propofol with intubation and mechanical ventilation
Patching and antiplatelet: not reported
Indication for shunting: LA: following carotid clamping, change in mental evaluation defined as agitation, confusion, contralateral weakness, seizure, unresponsiveness


OutcomesHemodynamic stability (mean arterial pressure), death, neurological deficit, cardiopulmonary complication


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "They were randomly assigned by means of a computer-generated random number table to receive 1 of 2 anaesthesia techniques"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported

Selective reporting (reporting bias)High riskNot all prespecified outcomes were reported, namely time to recovery of consciousness, perioperative complications such as nausea, vomiting, sweating, and grade on pain perception and comfort

Other biasHigh riskNot reported

Mazul-Sunko 2010

MethodsRCT
C: unclear
Blinding: unclear
Cross-over: unclear
Exclusion during trial: unclear
Losses to FU: unclear


ParticipantsCroatia 2010
57 patients, 57 operations
Mean age: 66.2 years (LA); 66 years (GA)

Percentage of male: 89.6% (LA) and 85.7% (GA)

Demographic data and baseline data are comparable
Indication for surgery: carotid stenosis 70% or more


InterventionsLA: superficial cervical plexus block by levobupivacaine (1.5 mg/kg) and supplemental infiltration by surgeons with 1% lidocaine
GA: etomidate in a dosage of 0.2 mg/kg and fentanyl (3 microgram/kg) for indication, vecuronium (0.08 mg/kg) for paralysis, maintain with isoflurane 0.7 to 1.2 MAC in a mixture of oxygen and nitrous oxide 50%:50%. Reversal with neostigmine (2.5 mg) and atropine (1 mg)

Indication for shunting: LA: following carotid clamping, neurological deficit. GA : routine shunting was used except when technical difficulties


OutcomesStroke, death, myocardial infarction, shunting


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Elective carotid CEA were prospectively randomised to received either general or regional anaesthesia"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported

Selective reporting (reporting bias)Low riskAll prespecified outcomes were reported

Other biasHigh riskNot reported

McCarthy 2004

MethodsRCT
C: unclear
Blinding: not reported
Cross-over: not reported
Exclusion during trial: none
Losses to FU: none


ParticipantsUK 2004
176 patients and 176 operations
Age (mean): 71 years (LA), 72 years (GA)
Male: 61% (LA), 68% (GA)
Comparability: groups similar for vascular risk factors
Indication for surgery: not reported


InterventionsLA: not reported
GA: not reported
Patching: not reported
Antiplatelet Rx: not reported
Indication for shunting: not reported


OutcomesStroke, TIA, myocardial infarction, wound complication


NotesFU: probably in-hospital stay
Ex: not reported


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote:"The CEA-EQ questionnaire was administered to 176 CEA patients, prospectively randomised to either GA or LA in two hospitals, the Royal United Hospital Bath and The General Informary, Leeds"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported

Selective reporting (reporting bias)High riskNo prespecified outcomes were reported

Other biasHigh riskNot reported

Moritz 2010

MethodsRCT
Computer random
Blinding: not reported
Cross-over: 2 patients crossed over from LA to GA but these 2 patients were excluded from study
Exclusion during trial: 6 (2 withdrawal of consent, 4 incomplete data)
Losses to FU: not report


ParticipantsGermany 2010
96 patients, 96 operations
Age (mean): of all participants, 69 years
Male: 68.8% (LA), 70.8% (GA)
Comparability for vascular risk factors, preoperative symptom, ASA classification

Indication for surgery: symptomatic 70% to 99%, asymptomatic 80% to 99%


InterventionsLA: superficial + deep cervical block by 1% prilocaine
GA: fentanyl, propofol, rocuronium and anaesthesia maintain by inspired sevoflurane, bolus fentanyl
Patching: not reported
Antiplatelet Rx: not reported
Indication for shunting for LA group was any neurological deterioration like speech abnormality, hemiparesis, or impaired consciousness

The indication for shunting in the GA group was N20/P25 amplitude of the somatosensory evoked potential decreased to or below 30% of the baseline value


OutcomesStroke, myocardial infarction, cardiopulmonary data (blood pressure, heart rate), comparison neuromonitoring various method i.e. stump pressure, transcranial Doppler, near-infrared spectroscopy, somatosensory evoked potentials


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "All patients were randomised to either sevoflurane/fentanyl anaesthesia (GA = general anaesthesia) or regional anaesthesia (RAI) using a computerized system"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: "a total of 106 patients were randomised to the sevoflurane/ fentanyl (n=53) and regional (n=53) anaesthesia groups. Four patients were excluded because of withdrawal of consent (2 in each group), 2 patients because of conversion to general anaesthesia, and 4 patients because of incomplete data acquisition (3 in GA and 1 in RA). Thus, the final analysis was conducted in 96 patients (GA: n=48; RA: n=48)"

Selective reporting (reporting bias)High riskAll prespecified outcome were reported

Other biasHigh riskNot reported

Mrozek 2007

MethodsRCT
C: unclear
Blinding: not reported
Cross-over: no crossovers from LA to GA
Exclusion during trial: not report
Losses to FU: not report


ParticipantsOlomouc 2007
80 patients, 80 operations
Age (mean): 67 years (LA), 67 years (GA)
Male: 55% (LA), 87.5% (GA)
Comparability for vascular risk factors: not reported
Indication for surgery: not reported


InterventionsLA: superficial + deep cervical block by 0.5% bupivacaine under neurostimulator
GA: intravenous etomide, thiopental, atracurium, midazolam, fentanyl and atracurium
Patching: not reported
Antiplatelet Rx: not reported
Indication for shunting in LA group was loss of consciousness and loss of motor function following carotid clamping

Indication for shunting in GA group: not reported


OutcomesHemodynamic parameter (blood pressure, pulse rate) death, stroke, myocardial infarction, patients' subjective feeling


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuote: "the patients were randomised into two groups according to the first six digits of their date of birth (YYMMDD): odds to CB and even to GA"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported

Selective reporting (reporting bias)Low riskAll prespecified outcomes were reported

Other biasHigh riskNot reported

Pluskwa 1989

MethodsRCT
C: random number list
Blinding: unclear
Cross-overs: none
Exclusions during trial: none
Losses to FU: none


ParticipantsFrance 1989
20 patients, 20 operations
Age (mean): 66 years (LA), 63 years (GA)
Male: 90% (LA), 70% (GA)
Comparability: groups similar for vascular risk factors
Indication for surgery: not reported


InterventionsLA: epidural (C7-T1) by bupivacaine and fentanyl
GA: flunitrazepam, fentanyl, vecuronium
Patching: not reported
Antiplatelet Rx: not reported
Indication for shunting: not reported


OutcomesDeath, any stroke, myocardial infarction, blood pressure


NotesFU: probably hospital discharge
Ex: bleeding risk, on anticoagulants


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "La veille de l'intervention. ces patients ont ete repartis en deux groupes par tirage au sort a partir d'une serie de nombres au hasard"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported

Selective reporting (reporting bias)High riskNot all prespecified outcomes were reported, namely heart rate

Other biasHigh riskNot reported

Prough 1989

MethodsRCT
C: unclear
Blinding: unclear
Cross-overs: none
Exclusions during trial: none
Losses to FU: none


ParticipantsUSA 1989
23 patients, 23 operations
Age (mean): 67 years (LA), 61 years (GA)
Male: 69% (LA), 40% (GA)
Comparability: groups similar for preoperative physical status
Indication for surgery: not reported


InterventionsLA: superficial cervical block
GA: thiopental, pancuronium, isoflurane
Patching and antiplatelet Rx: not reported
Indication for shunting: not reported


OutcomesDeath, any stroke, myocardial infarction, blood pressure


NotesFU: probable hospital discharge
Ex: 5 patients refused GA so not randomised


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: "Patients who consented to either form of anaesthesia were randomised to received regional or general anaesthesia"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
High riskNot reported

Selective reporting (reporting bias)High riskNot all prespecified outcomes were reported, namely intraoperative and postoperative intravenous fluid administration and urine output

Other biasHigh riskNot reported

Sbarigia 1999

MethodsRCT
Randomisation: casual number
C: unclear
Blinding: assessor (neurologist)
Cross-overs: 2 exclusions during trials
Losses to FU: 18


ParticipantsItaly 1995 to 1998
107 patients, 107 operations
Age (mean): 69.0 years (LA), 70.4 years (GA)
Males: 87.3% (LA), 88.5% (GA)
Comparability: groups similar for vascular risk factors
Indication for surgery: TIA, asymptomatic carotid stenosis > 70%, stroke


InterventionsLA: superficial and deep cervical block with bupivacaine
GA: alfentanil + propofol or sodium thiopental + fentanyl + isoflurane or vecuronium + nitrous oxide
Patching: LA 36.4%, GA 23.1%
Antiplatelet Rx: not reported
Indication for shunting: LA: neurological test (toy-squeaker squeezing test); GA: not reported


OutcomesDeath, any stroke, myocardial infarction, TIA, bleeding, cranial nerve injuries, shunted arteries


NotesFU: 30 days
Ex: clinical signs of congestive heart disease, severe valvular heart disease, unstable angina, left bundle branch block (by ECG)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "randomization by means of causal numbers"

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
Low risk2 cross from LA to GA, no drop outs
Quote: "two patients were excluded after randomisation and the operations were done under GA"; "in both cases, the anaesthesiologist considered the infiltration of LA to be dangerous"

Selective reporting (reporting bias)High riskNo prespecified outcome was available

Other biasHigh riskNot reported

Sindelic 2004

MethodsRCT
Randomisation, concealment and blinding of assessor: unclear
Cross-over: unclear
Losses to FU: unclear


ParticipantsSerbia
50 patients, 50 operations
Mean age: 64.4 years (GA), 65.9 years (LA)
Comparability of 2 groups in vascular risk factors
Indication for surgery: unclear
Males: 56% (GA), 52% (LA)


InterventionsLA: superficial and deep cervical plexus block: superficial block was done with 15 cc 0.5% bupivacaine and 5 cc 2% lidocaine injection along posterior border of sternocleidomastoid muscle
Deep cervical block was performed with 3 injection techniques for blockages of C2, C3 and C4 segment
GA: thiopental + fentanyl + rocuronium
Patching and antiplatelet Rx and indication for shunting: not reported


OutcomesBlood pressure


NotesFU and Ex: unclear


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: " Bolesnici su randomizirani u jednu od dve grupe, shodno anestezioloskim postupeima koji ce se sprovesti u toku operaciji: grupe opste anestezije (OA) i grupe regionalne anesezije (RA)."

Allocation concealment (selection bias)High riskNot reported

Blinding of participants and personnel (performance bias)
All outcomes
High riskPatients and surgeons were not blinded to treatment group

Blinding of outcome assessment (detection bias)
All outcomes
High riskNot reported

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo patients lost

Selective reporting (reporting bias)High riskSelected to report parameters only at T2 time which is the only one that is significant but not pre-specified
Quote: "Zbog znacajna medjugrupna u grupi OA postojiu vremenu T2 i znacajna razlika u tom vremenu (OA vs RA,p < 0.01)"

Other biasHigh riskNot reported

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Ebner 2008Randomised allocation was based on the rotation of two anaesthetists who could perform cervical plexus block

 
Comparison 1. Local versus general anaesthetic: randomised trials

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

 1 Any stroke within 30 days of operation124453Peto Odds Ratio (Peto, Fixed, 95% CI)0.92 [0.67, 1.28]

 2 Death within 30 days of operation104181Peto Odds Ratio (Peto, Fixed, 95% CI)0.61 [0.35, 1.06]

 3 Stroke or death within 30 days of operation104181Peto Odds Ratio (Peto, Fixed, 95% CI)0.85 [0.62, 1.16]

 4 Myocardial infarction within 30 days of operation114357Peto Odds Ratio (Peto, Fixed, 95% CI)1.53 [0.67, 3.47]

 5 Local haemorrhage53976Peto Odds Ratio (Peto, Fixed, 95% CI)0.95 [0.75, 1.19]

 6 Cranial nerve injuries43865Peto Odds Ratio (Peto, Fixed, 95% CI)1.17 [0.95, 1.44]

 7 Arteries shunted84133Odds Ratio (M-H, Random, 95% CI)0.24 [0.08, 0.73]