A randomized controlled trial evaluating general endotracheal anesthesia versus monitored anesthesia care and the incidence of sedation-related adverse events during ERCP in high-risk patients
Abstract
BACKGROUND AND AIMS
ERCP is a complex procedure often performed in patients at high risk for sedation-related adverse events (SRAEs). However, there is no current standard of care with regard to mode of sedation and airway management during ERCP. The aim of this study was to assess the safety of general endotracheal anesthesia (GEA) versus propofol-based monitored anesthesia care (MAC) without endotracheal intubation in patients undergoing ERCP at high risk for SRAEs.
METHODS
Consecutive patients undergoing ERCP at high risk for SRAEs at a single center were invited to participate in this randomized controlled trial comparing GEA and MAC. Inclusion criteria were STOP-BANG score ≥3, abdominal ascites, body mass index ≥35, chronic lung disease, American Society of Anesthesiologists class >3, Mallampati class 4 airway, and moderate to heavy alcohol use. Exclusion criteria were preceding EUS, emergent ERCP, tracheostomy, unstable airway, gastric outlet obstruction or delayed gastric emptying, and altered foregut anatomy. The primary endpoint was composite incidence of SRAEs: hypoxemia, use of airway maneuvers, hypotension requiring vasopressors, sedation-related procedure interruption, cardiac arrhythmia, and respiratory failure. Secondary outcomes included procedure duration, cannulation success, in-room time, and immediate adverse events.
RESULTS
Two hundred patients (mean age, 61.1 ± 13.6 years; 36.5% women) were randomly assigned to GEA (n = 101) or MAC (n = 99) groups.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 101 participants or records.
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