Randomized trial comparing general anesthesia with anesthesiologist-administered deep sedation for ERCP in average-risk patients

Abstract

General anesthesia (GA) or monitored anesthesia care (MAC) is increasingly used to perform ERCP. The definitive choice between the 2 sedative types remains to be established. This study compared outcomes of GA with MAC in ERCP performed in patients at average risk for sedation-related adverse events (SRAEs). At a tertiary referral center, patients with American Society of Anesthesiologists (ASA) class≤III were randomly assigned to undergo ERCP with MAC or GA. The main outcome was a composite of hypotension, arrhythmia, hypoxia, hypercapnia, apnea, and procedural interruption or termination defined as SRAEs. In addition, ERCP procedural time, success, adverse events, and endoscopist and patient satisfaction were compared. Of 204 randomized, 203 patients were evaluated for SRAEs (MAC, n= 96; GA, n= 107). SRAEs developed in 35% of the MAC cohort (34/96) versus 9% in the GA cohort (10/107), which was statistically significant (P< .001). Mean induction time for GA was significantly longer than that for MAC (10.3 ± 10 minutes vs 6.5 ± 10.8 minutes, respectively; P< .001). ERCP procedure time, recovery time, cannulation time and success, and procedure-related adverse events were not statistically different between the 2 sedative groups. The use of GA improved endoscopist and patient satisfaction (P< .001). GA is safe with fewer SRAEs than MAC in patients with ASA scores≤III undergoing ERCP. Apart from prolonging induction time, use of GA does not change the procedural success or ERCP-related adverse events and offers greater endoscopist and patient satisfaction. Hence, GA is a consideration in patients undergoing ERCP in this population group. (Clinical trial registration number: NCT04099693.).