935 A RANDOMIZED-CONTROLLED TRIAL EVALUATING THE USE OF GENERAL ENDOTRACHEAL ANESTHESIA COMPARED WITH MONITORED ANESTHESIA CARE WITHOUT AN ENDOTRACHEAL TUBE AND THE INCIDENCE OF SEDATION-RELATEDADVERSE EVENTS DURING ERCP IN HIGH-RISK PATIENTS

Abstract

ERCP is a complex procedure which is often performed in patients at high risk for sedation-related adverse events (SRAE). There is currently no standard of care with regard to mode of anesthesia and airway management during ERCP. The aim of this study was to compare the safety of general endotracheal anesthesia (GEA) vs propofol-based monitored anesthesia care (MAC) in patients at high risk for SRAE undergoing ERCP. Consecutive patients with a high risk for SRAE undergoing ERCP 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, 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 and altered foregut anatomy. The primary end point was composite incidence of SRAE: [hypoxia (SpO2 < 90%) requiring airway maneuvers (nasal airway, oral airway, chin lift, jaw thrust or bag max ventilation)], hypotension requiring vasopressors, sedation-related procedure interruption, cardiac arrhythmia and respiratory failure. Secondary outcomes included procedure duration, cannulation success, in-room time and immediate complications. Two hundred patients (mean age 61.1±13.6 years, 36.5% female) were randomly assigned to GEA (n=101) and MAC (n=99). Univariate analyses of patient demographic and baseline variables are outlined in Table 1. Aside from higher STOP-BANG scores in the GEA group, the cohorts were well matched. Composite SRAE were significantly more in the MAC group compared with GEA (51% vs 9.1%, p<0.001). This was primarily driven by the frequent need for airway maneuvers in the MAC group (Table 2). 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 AM (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 (Table 2). 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. In patients at high risk for SRAE undergoing ERCP, GEA is associated with a significantly lower incidence of SRAE, without impacting procedure duration, success rate, recovery time, or in-room procedure time. Additionally, use of MAC in this high-risk cohort resulted in the need for procedure interruption and conversion to GEA 10.1% of cases. These data suggest that GEA should be utilized for ERCP in patients at high risk for sedation-related adverse events.Tabled 1Univariate analyses of patient demographic and baseline variablesGEAMACp-valueAgeMean60.961.30.501Standard Deviation14.013.2SexMen64570.470Women3742StatusInpatient3933Outpatient6266STOP-BANG ScoreMean4.434.010.030Standard Deviation1.371.32Ascites1030.082BMI≥3527271.00Chronic lung disease25200.500ASA Class >38100.629Mallampati Class 4441.00Alcohol Use101.00Trainee Involved in ERCP37440.313Procedure IndicationCholedocholithiasis26260.470Biliary stricture5250Chronic pancreatitis910Bile leak47Acute pancreatitis45Other61 Open table in a new tab Tabled 1Study OutcomesMeanStandard Deviationp-valueCannulation time (hours:min)MAC0:090:140.331GEA0:070:11Total room time (min)MAC53:8723:970.241GEA57:5920:70Total procedure time (min)MAC25:0920:370.914GEA25:4019:58Total fluoroscopy time (min:sec)MAC7:065:280.996GEA7:074:46MACGEAp-valueHypotension requiring vasopressorNo90911.00Yes910Cannulation successNo221.00Yes9799HypoxiaNo80960.002Yes195Airway maneuversTotal450<0.001Nasal airway310<0.001Oral airway400.209Chin lift900.001Jaw thrust600.014Bag mask ventilation800.003Aldrete score (calculated on arrival to recovery)8.7±0.78.5±0.60.120 Open table in a new tab