Abstract / Summary
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. Results: Intraprocedural mean systolic blood pressure was 128.46 ± 10.97 mmHg in Group A and 121.42 ± 15.19 mmHg in Group B (p = 0.0092), whereas mean arterial pressure did not differ significantly. Mean heart rate was 103.02 ± 12.01 beats/min in Group A and 97.12 ± 9.11 beats/min in Group B (p = 0.0068). The lower intraprocedural systolic blood pressure and heart rate in Group B may reflect better patient compliance and analgesia. Mean SpO₂ was 98.30 ± 2.52% in Group A and 99.28 ± 1.58% in Group B (p = 0.0222), and apnoea occurred more often in Group A (12% vs 4%). Post-procedural haemodynamic and respiratory parameters were also better in Group B. Mean post-procedural VAS score was 5.16 ± 1.04 in Group A and 3.64 ± 0.86 in Group B (p < 0.0001), and mean Modified Aldrete Score was 7.44 ± 0.82 in Group A and 8.58 ± 0.56 in Group B (p < 0.0001). Post-procedural adverse effects were less frequent in Group B. Conclusion: Both intraprocedural and post-procedural haemodynamic and respiratory profiles were better maintained with propofol–fentanyl than with propofol–midazolam. The propofol–fentanyl group also had superior post-procedural analgesia, faster recovery and fewer adverse effects. Propofol–fentanyl may therefore be the preferable drug combination for patients undergoing ERCP.