A prospective assessment of sedation-related adverse events and patient and endoscopist satisfaction in ERCP with anesthesiologist-administered sedation

Abstract

Background: Despite the increasing use of anesthesiologist-administered sedation for monitored anesthesia care (MAC) or general anesthesia in patients undergoing ERCP, limited prospective data exist on the effectiveness, safety, and cost of this approach.

Objective: To prospectively assess sedation-related adverse events (SRAEs), patient- and procedure-related risk factors associated with SRAEs, and endoscopist and patient satisfaction with anesthesiologist-administered sedation.

Design: Single-center, prospective cohort study.

Setting: Tertiary-care referral center.

Patients: A total of 528 consecutive patients undergoing ERCP.

Interventions: Anesthesiologist-administered MAC or general anesthesia.

Main outcome measurements: SRAEs, endoscopist and patient satisfaction.

Results: There were 120 intraprocedure SRAEs during 109 of the 528 ERCPs (21% of cases). Intraprocedure SRAEs included hypotension (38 events), arrhythmia (20 events), O(2) desaturation to less than 85% (66 events), unplanned intubation (16 events), and procedure termination (1 event). Thirty postprocedure SRAEs occurred in a total of 22 patients (4% of cases), including hypotension (5 events), endotracheal intubation (2 events), and arrhythmia (12 events). Patient-related variables associated with adverse intraprocedure events were American Society of Anesthesiologists class (P = .004) and body mass index (kg/m(2)) (P = .02). On a 10-point scale, mean endoscopist satisfaction with sedation was 9.2 (standard deviation 1.8) and patient satisfaction with sedation was 9.9 (standard deviation 0.7).

Limitations: The approach to sedation was not randomized.

Conclusions: Higher American Society of Anesthesiologists class and body mass index are associated with an increased rate of cardiac and respiratory events during ERCP. Cardiac and respiratory events are generally minor, and MAC can be considered a safe option for most ERCP patients. Despite the frequency of minor sedation-related events, procedure interruption or premature termination was rare in the setting of anesthesiologist-administered sedation.