A Randomized Controlled Trial on Use of Propofol Alone Versus Propofol with Midazolam, Ketamine, and Pentazocine "sedato-analgesic Cocktail" for Sedation During ERCP

Background And Aims: Endoscopic retrograde cholangiopancreatography (ERCP) requires adequate patient sedation in order to carry out the procedure successfully. Propofol sedation is being increasingly used during ERCP. There are limited data to evaluate the efficacy of synergistic agents with propofol for sedation during ERCP. The aims of the current study were: (i) to compare patient sedation and tolerance during ERCP using either propofol alone or a "sedato-analgesic cocktail" for induction, along with propofol for maintenance, and (ii) to prospectively compare complications related to both sedation regimens.

Patients And Methods: This was a double-blind, randomized controlled trial with patients receiving either intravenous propofol alone (Group A) or a sedato-analgesic cocktail (midazolam, ketamine, and pentazocine plus propofol) (Group B) for induction; all patients received propofol for maintenance. Patient sedation and tolerance were assessed using 100-mm visual analog scales (VAS).

Results: A total of 199 patients undergoing ERCP were randomized (Group A, n = 104 vs. Group B, n = 95). Clinical characteristics were similar in both groups. Patient tolerance VAS scores were higher in Group B when assessed independently by both endoscopist ( P = 0.002) and anesthetist ( P = 0.001). The differences in scores occurred predominantly in younger patients. The mean propofol requirement was 192 mg in Group A and 131 mg in Group B; the mean difference was 61 mg (95%CI 40-82 mg). Patients reported equivalent levels of satisfaction with both sedation regimens. On multivariate analysis, "cocktail" use ( P = 0.013) and increasing age ( P = 0.027) significantly improved patient tolerance during ERCP. Caution during "cocktail" induction is required as transient oxygen desaturation occurs.

Conclusion: During ERCP, propofol with a sedato-analgesic cocktail for induction results in improved patient tolerance compared with propofol alone, particularly in younger patients. Generalizations from this study to the Western world and to different cultural groups require further study.