Randomized controlled trial for endoscopy with propofol versus midazolam on psychometric tests and critical flicker frequency in people with cirrhosis
- Clinical trial no-NCT01356121.
- Individual contributions: Agrawal Amit: Collection of data and manuscript writing; Sharma Barjesh Chander: monitoring of data and expert guidance; Sharma Praveen: analysis of data and manuscript writing; Rajiv Uppal: patient monitoring and collection of data; Sarin Shiv Kumar: expert editing of manuscript.
Dr B. C. Sharma, Department of Gastroenterology, Room 203, Academic Block, G. B. Pant Hospital, New Delhi 110002, India. Email: firstname.lastname@example.org
Background and Aim
People with cirrhosis are at increased risk of development of complications related to sedation. The aim of the present study was to compare the effects of sedation for upper gastrointestinal endoscopy (UGIE) with propofol and midazolam on psychometric tests and critical flicker frequency (CFF) in people with cirrhosis.
A total of 127 people with cirrhosis were randomized into three groups: propofol group (n = 40), midazolam group (n = 42) and no sedation (n = 45). All patients underwent CFF test and combination of psychometry (number connection test-A and B [NCT-A,B]; digit symbol test [DST], line tracing test [LTT] and serial dotting test [SDT]) at baseline and at 2 h post-endoscopy. CFF was done at 30 min and repeated every 30 min for 2 h.
In the propofol group there was no deterioration in psychometry (NCT-A [55.6 ± 18.7 vs 56.4 ± 19.0 s], NCT-B [98.2 ± 35.1 vs 97.8 ± 34.6 s], DST [26.7 ± 5.7 vs 26.3 ± 5.3], LTT [112.9 ± 35.7 vs 113.7 ± 36.6 s], SDT [94.6 ± 34.1 vs 95.2 ± 34.5 s]). Significant deterioration from baseline (39.8 ± 2.9 Hz) was seen in CFF at 30 min (38.8 ± 2.3 Hz) and 1 h (39.2 ± 2.4 Hz), P = 0.01 but no difference thereafter. In the midazolam group, significant deterioration was observed on psychometry (NCT-A [56.0 ± 18.5 vs 60.4 ± 19.8 s], NCT-B [99.9 ± 29.1 vs 105.9.6 ± 30.3 s], DST [26.1 ± 4.7 vs 25.2 ± 4.3], LTT [129.1 ± 34.5 vs 132.9 ± 35.4 s], SDT [95.6 ± 34.2]). No deterioration was observed in psychometry and CFF in people with cirrhosis without sedation.
Propofol sedation for UGIE was associated with earlier recovery compared with midazolam, which causes deterioration of psychometric tests and CFF for a longer time in comparison with propofol.