Deep sedation for endoscopic retrograde cholangiopancreatography: intravenous propofol alone versus intravenous propofol with oral midazolam premedication.

BACKGROUND AND STUDY AIMS: The primary objective of the present study was to compare the dosage of intravenous propofol required in patients being sedated with propofol alone (group P) with the dosage of propofol required in patients who also received an oral dose of midazolam (group M + P) for endoscopic retrograde cholangiopancreatography (ERCP) procedures. The secondary objectives were to compare the two groups with regard to patient anxiety levels before the procedure, patient satisfaction, the recovery time, and the adverse events related to sedation. PATIENTS AND METHODS: A total of 91 consecutive patients undergoing ERCP were randomly assigned to one of the two medication regimens. Patients in group P (n = 45) received only intravenous propofol, titrated to achieve deep sedation. Patients in group M + P (n = 46) received 7.5 mg of midazolam orally 30 minutes before being given intravenous propofol, which was similarly titrated to achieve deep sedation.
RESULTS: Patients receiving propofol alone required higher doses of propofol compared with those receiving synergistic sedation (512 +/- 238 mg vs. 330 +/- 223 mg respectively, P < 0.001). The patients' anxiety levels before the procedure were lower in group M + P patients than in group P patients (P < 0.001). The mean percentage decline in oxygen saturation during the procedure was significantly greater in group P patients than it was in group M + P patients. A significant drop in the oxygen saturation (to < 90 %) occurred in 11 group P patients and in three group M + P patients (P = 0.02).
CONCLUSIONS: Our data suggest that synergistic sedation with an oral dose of midazolam combined with intravenous propofol can provide a significant benefit, with a reduction in the dosage of propofol required and in patient anxiety levels before ERCP.

RCT Entities:   Population Interventions Outcomes