Propofol is a more effective and safer sedative agent than midazolam in endoscopic injection sclerotherapy for esophageal varices in patients with liver cirrhosis: a randomized controlled trial

Objective: The efficacy of sedation during endoscopic injection sclerotherapy (EIS) for esophageal varices (EVs) in patients with liver cirrhosis remains unclear. The aim of this study is to compare the efficacy and safety between propofol- and midazolam-based sedation for EIS. Methods: Twenty-three patients with EVs were prospectively and randomly assigned to midazolam-based (Midazolam group) or propofol-based (Propofol group) sedation. All patients underwent a number connection test (NCT) to evaluate minimal hepatic encephalopathy (MHE) on the day before and at 2 and 24 hours following EIS. The primary endpoint was exacerbation of MHE after EIS, which was defined as deterioration of the NCT. The secondary endpoints were postoperative awareness, technical success rate, frequency of body movement, patient and operator satisfaction, cardiorespiratory dynamics during EIS, and adverse events. Results: Exacerbations of MHE at 2 hours after EIS compared with those before EIS were not significantly different between the two groups. In both groups, the deterioration of NCT scores before and 2 hours after EIS was observed (Propofol group: 60.0 vs. 70.0 s, P = 0.026; Midazolam group: 42.5 vs. 67.0 s, P = 0.002). There were no significant differences in awareness, technical success rate, or patient satisfaction. However, the frequency of body movement in the Propofol group was significantly lower than that in the Midazolam group (1 vs. 4, P = 0.045), and operator satisfaction in the Propofol group was significantly higher than that in the Midazolam group (P = 0.016). No adverse events were observed. Conclusions: Propofol-based sedation exacerbated MHE after EIS similarly to midazolam-based sedation in patients with liver cirrhosis. However, propofol-based sedation provided stable sedation with a lower frequency of body movements and high operator satisfaction