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.Smith ZL, Mullady DK, Lang GD, Das KK, Hovis RM, Patel RS, Hollander TG, Elsner J, Ifune C, Kushnir VM. Gastrointest Endosc. 2018 Sep 11. [Epub ahead of print]
BACKGROUND AND AIMS:ERCP is a complex procedure and often performed in patients at high risk for sedation-related adverse events (SRAE). 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 without endotracheal intubation (MAC) in patients undergoing ERCP at high risk for SRAE.
METHODS:Consecutive patients undergoing ERCP at high risk for SRAE at a single center were invited to participate in this randomized-controlled trial (NCT02850887) comparing GEA and MAC. Inclusion criteria were: STOP-BANG score of ≥3, abdominal ascites, body mass index (BMI) ≥35, chronic lung disease, ASA class >3, Mallampati class 4 airway, 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 SRAE: (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% female) were randomly assigned to GEA (n=101) or MAC (n=99). Composite SRAE were significantly higher in the MAC group compared with GEA (51.5% vs 9.9%, p<0.001). This was primarily driven by the frequent need for airway maneuvers in the MAC group. Additionally, ERCP was interrupted in 10.1% of patients in the MAC group in order to convert to GEA due to respiratory instability refractory to airway maneuvers (n=8) or significant retained gastric contents (n=2). There were no statistically significant differences in cannulation, in-room, procedure or fluoroscopy times between the two groups. All patients undergoing GEA were successfully extubated in the procedure room at completion of ERCP and Aldrete scores in recovery did not differ between the two groups. There were no immediate adverse events.CONCLUSION:In patients at high risk for SRAE undergoing ERCP, sedation with GEA is associated with a significantly lower incidence of SRAE, without impacting procedure duration, success, recovery, or in-room time. These data suggest that GEA should be used for ERCP in patients at high risk for sedation-related adverse events Leggi l’articolo