Combination use of intravenous ketamine-midazolam as a sedative agent in endoscopic retrograde cholangiopancreatography: a randomized control trial

Endoscopic retrograde cholangiopancreatography (ERCP) is an invasive endoscopic procedure that requires deep sedation of the patient. Propofol is the most widely used sedative for advanced endoscopic procedures. However, its use is constrained by high cost and the need for administration by an anaesthetist. Our study aims evaluate the efficacy of ketamine-midazolam as a sedative agent during ERCP, assessing the depth of sedation. This prospective single-blinded randomized control trial (RCT) including patients undergoing ERCP. Patients were randomly assigned to either ketamine-midazolam or midazolam-pethidine combination. Depth of sedation was measured using the Ramsay sedation scale while the endoscopist and patient satisfaction scores, sedation failure rate, sedation-related complication, sedation failure were systematically recorded. A total of 85 patients were included in this study, with 42 in the intervention arm and 43 in controlled arm. The intervention group demonstrated significantly deeper sedation at various stages of the procedure: scope intubation (RSS 5.6 vs. 4.42, P < 0.001), common bile duct cannulation (RSS 5.87 vs. 4.9, P < 0.001), sphincterotomy (RSS 5.7 vs. 4.95, P < 0.005), and scope withdrawal (RSS 5.71 vs. 4.86, P < 0.01). Both patients (9.19 vs. 7.31, P < 0.001) and endoscopist (4.79 vs. 3.86, P < 0.001) reported higher satisfaction scores in the ketamine-midazolam group. The combination of ketamine-midazolam offers a potentially safer and more effective sedation strategy compared to midazolam and pethidine for procedural sedation. This is primarily attributed to ketamine’s favourable respiratory and hemodynamic profile along with its combined sedative and analgesic effects. Clinical trials.gov ID: NCT06111872 (01/11/2023).