Addition of Dexmedetomidine and Nalbuphine As an Adjuvant to Ketofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: A Prospective, Randomized, Double-Blind Study

Background: Deep sedation has evolved as a better choice against general anesthesia in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP). This study was aimed to evaluate the efficacy of dexmedetomidine and nalbuphine as an adjuvant to ketofol based deep sedation in ERCP. Methods: One hundred patients undergoing ERCP were randomly assigned to receive either IV dexmedetomidine 1 μg/kg (Group D, n = 50) or I. V nalbuphine 0.1 μg/kg (Group N, n = 50), 10 min before ketofol induction. The primary outcome was the total dose of ketofol used for induction and maintenance of deep sedation throughout the procedure. Hemodynamics and respiratory parameters, recovery characteristics, endoscopist's, and anesthetist satisfaction scores were secondary outcomes. P < 0.05 was considered statistically significant. Results: The dose of ketofol at the time of induction was significantly high in Group N as compared to Group D (P < 0.05). Supplemental dose of ketofol at the time of insertion of endoscope was equivalent in both the groups (P > 0.05) but significantly more number of patients in Group D (n = 19 vs. n = 11, P < 0.05) received supplement for facial pain score >5 compared to patients in Group N, where more patients received supplement for Ramsay Sedation Score <3 (n = 20 vs. n = 11 P < 0.05). Significant decrease in heart rate (HR) and mean arterial pressure from baseline values was found in Group D as compared to Group N (P < 0.001). Group N patients achieved postanesthesia recovery score >12 earlier than Group D (P < 0.001). Anesthetist satisfaction score was more in Group N (P < 0.05). Conclusion: Dexmedetomidine reduces the total consumption of ketofol and provides smooth hemodynamics whereas Nalbuphine provides better analgesia and early recovery with high anesthetist satisfaction for deep sedation in ERCP.