Sedative and Analgesic Effects of Propofol-Fentanyl Versus Propofol-Ketamine During Endoscopic Retrograde Cholangiopancreatography: A Double-Blind Randomized Clinical Trial

Abstract

Background: Endoscopic retrograde cholangiopancreatography (ERCP) is a painful procedure that requires analgesia and sedation. Objectives: In this study, we compared the analgesic and sedative effects of propofol-ketamine versus propofol-fentanyl in patients undergoing ERCP. Methods: In this clinical trial, 72 patients, aged 30 - 70 years old, who were candidates for ERCP were randomly divided into two groups. Before the start of ERCP, both groups received midazolam 0.5 - 1 mg. The intervention group (PK) received ketamine 0.5 mg/kg, and the control group (PF) received fentanyl 50 - 100 micrograms. All patients received propofol 0.5 mg/kg in a loading dose followed by 75 mcg/kg/minute in an infusion. The patients, the anesthesiologist, and the endoscopist were unaware of the medication regimen. Sedation and analgesia quality (based on a VAS), blood pressure, respiratory rate, heart rate, arterial oxygen saturation, recovery time (based on Aldrete scores), and endoscopist and patient satisfation were recorded. Results: The sedative effects were equal in the two groups (P > 0.05), but the analgesic effects were higher in the PF group than in the PK group (P < 0.05). The PK group had higher blood pressure levels in the eighth minute. Respiratory rate, heart rate, and arterial oxygen saturation showed no significant differences between the groups (P > 0.05). Endoscopist satisfaction, patient satisfaction, and recovery time showed no significant differences between the two groups (P > 0.05). Conclusions: The results showed that the sedative effect of propofol-ketamine was equal to the propofol-fentanyl combination during ERCP. To prevent respiratory and hemodynamic complications during ERCP, the propofol-ketamine combination should be used in patients with underlying disease.