Evaluating a Modified American Society of Anesthesiologists Physical Status‐Based Sedation Management System for Pancreatobiliary Endoscopy: A Prospective Feasibility Study

ABSTRACT Objectives To prospectively evaluate the feasibility of implementing a modified American Society of Anesthesiologists Physical Status (ASA‐PS)‐based sedation management system for endoscopist‐managed sedation in pancreatobiliary endoscopy. Methods This single‐center, single‐arm prospective feasibility study involved 2000 patients (2024–2025). Sedation risk was stratified using a modified ASA‐PS classification system combined with predefined high‐risk clinical factors (severe obesity, obstructive sleep apnea requiring continuous positive airway pressure, chronic obstructive pulmonary disease requiring home oxygen therapy, reduced functional capacity, and difficult sedation history). Patients meeting high‐risk criteria underwent pre‐procedural anesthesiologist assessment to determine sedation providers. The primary outcome was sedation‐related adverse event (SRAE) incidence during endoscopist‐managed sedation. The secondary outcomes were the sedation success rate and SRAE‐associated risk factors. Results Among 2000 patients, 231 (11.6%) were classified as having high risk for sedation. Post‐assessment, anesthesiologists and endoscopists managed sedation for 86 (4.3%) and 1914 (95.7%) patients, respectively. In the endoscopist‐managed group, SRAEs occurred in 63 patients (3.3%), corresponding to a success rate of 96.7%. No patient required tracheal intubation or conversion to general anesthesia. In multivariable analysis, endoscopic ultrasonography‐guided sampling was independently associated with reduced SRAEs (odds ratio 0.407, 95% confidence interval 0.184–0.899; p = 0.026); no independent predictors of increased SRAEs were identified. Conclusions The modified ASA‐PS‐based sedation management system may be a feasible approach in settings with limited anesthesiology resources, warranting further validation. Trial Registration UMIN000053211