A comparative study between propofol–fentanyl and propofol–midazolam in patients undergoing endoscopic retrograde cholangiopancreatography (ercp): A parallel-group, double-blinded, randomized clinical trial

Background

Endoscopic retrograde cholangiopancreatography (ERCP) is a standard diagnostic and therapeutic procedure for disorders of the biliary and pancreatic ducts. It lasts 30 to 60 minutes and requires the patient to remain in an uncomfortable prone or semi-prone position, so it is usually performed under moderate-to-deep sedation with adequate analgesia. This study compared intravenous propofol combined with fentanyl against propofol combined with midazolam for induction and maintenance of sedation in patients undergoing ERCP. The primary objective was to compare intraprocedural haemodynamic and respiratory parameters between the two groups. Secondary objectives were to compare post-procedural analgesia (visual analogue scale, VAS), recovery (Modified Aldrete Score), post-procedural nausea, vomiting or other unpleasant sensations, and the post-procedural haemodynamic and respiratory profile. Materials and Methods: One hundred consenting adult patients were randomly allocated by computer-generated randomization into two equal groups of 50. Group A received intravenous propofol (1.5 mg/kg bolus, then titrated to requirement up to 100 mg) with midazolam 2 mg, and Group B received propofol in the same regimen with fentanyl 50 μg. Study parameters and post-procedural complications (nausea, vomiting and others) were recorded.