Ketamine and dexmedetomidine (Keto-dex) or ketamine and propofol (Keto-fol) for procedural sedation during endoscopic retrograde cholangiopancreatography: Which is safer? A randomized clinical trial

Abstract

Background: Optimum procedural sedation is very essential for conducting non-operating room procedures such as endoscopic retrograde cholangiopancreatography (ERCP). The combination of ketamine and dexmedetomidine (KD) is expected to balance out the undesirable effects of either drug and provide smooth sedation. Together ketamine and propofol (KP) also provide synergistic sedation with stable hemodynamics. This prospective, single-blinded randomized study aimed to compare the effect of both the combinations during ERCP in terms of oxygen desaturation, respiratory depression, hemodynamic parameters, analgesia, recovery time, and ease with which the endoscopist could perform the endoscopy.

Methods: This prospective, single-blinded randomized study (CTRI/2019/08/020625) was conducted on 84, ASA (American Society of Anesthesiologists) physical status I or II patients, of age 18-65 years presenting for ERCP in a tertiary care center. They were randomized to receive either KD (n=42) or KP (n=42) combination during ERCP. Mean SPO₂ at the end of the procedure was compared between the groups. Apart from these periprocedural hemodynamic and respiratory parameters, pain scores on arrival in the recovery room (t0), 15 minutes (t15), and 30 minutes (t30), recovery time, and endoscopist's satisfaction as per a Likert's scale were recorded.

Results: The mean SpO₂ (SpO₂ recorded every minute during the procedure and averaged over procedure time in minutes) in group KP (97.7 [96.1-98.6]) was significantly lower than group KD (98.5 [98.1-98.8]) (p=0.005). The post-procedure pain scores measured at t0 and t15 were higher in group KP (p<0.001 and p=0.043), and comparable at t30 in both the groups (p=0.711). The time to achieve Modified Aldrete score (MAS) ≥ 9 was significantly more in group KD (p<0.001). The lowest mean arterial pressure and heart rate in group KD were significantly lower than in group KP (p<0.001, p=0.006, respectively). The overall endoscopist satisfaction was better in group KP compared to group KD (p= 0.011).

Conclusions: The combination of ketamine-dexmedetomidine for procedural sedation during ERCP is a safe alternative to ketamine-propofol with a better respiratory profile.

Clinical trial number and registry url: CTRI/2019/08/020625 ( www.ctri.nic.in ).

Keywords: Desaturation; Dexmedetomidine; Ketamine; Non-operating room anesthesia; Propofol; Recovery time; Synergistic sedation.