To compare sedation with a combination of propofol plus fentanyl and midazolam plus fentanyl in cirrhotic outpatients undergoing UGIE.
A prospective, randomized, controlled trial was conducted between February 2008 and February 2009.
Efficacy (proportion of complete procedures using the initial proposed sedation scheme), safety (occurrence of sedation-related complications), and recovery time were measured.
Two hundred ten cirrhotic patients referred for UGIE were randomized to 2 groups: midazolam group (0.05 mg/kg plus fentanyl 50 μg intravenously) or propofol group (0.25 mg/kg plus fentanyl 50 μg intravenously). There were no differences between groups regarding age, sex, weight, etiology of cirrhosis, and Child-Pugh or American Society of Anesthesiologists classification. Sedation with propofol was more efficacious (100 % vs 88.2 % ; P < .001) and had a shorter recovery time than sedation with midazolam (16.23 ± 6.84 minutes and 27.40 ± 17.19 minutes, respectively; P < .001). Complication rates were similar in both groups (14 % vs 7.3 % ; P = .172).
Single-blind study; sample size.
Both sedation schemes were safe in this setting. Sedation with propofol plus fentanyl was more efficacious with a shorter recovery time compared with midazolam plus fentanyl. Therefore, the former scheme is an alternative when sedating cirrhotic patients undergoing UGIE.