Effect of deep analgosedation vs. intubated general anesthesia on perioperative sedation-related adverse events in older adults undergoing ERCP: protocol for a randomized controlled trial.

BACKGROUND: Deep analgosedation (DAS) and general anesthesia (GA) are currently the predominant anesthetic approaches for endoscopic retrograde cholangiopancreatography (ERCP). In contrast to DAS, GA typically requires endotracheal intubation for airway management. To determine the optimal analgosedation strategy, this study is designed to compare the effect of nasopharyngeal airway-assisted DAS (NPA-assisted DAS) vs. endotracheal intubation GA on perioperative sedation-related adverse events (SRAEs) in elderly ERCP patients.

METHODS: Patients scheduled for ERCP will be randomly assigned in a 1:1 ratio to NPA-assisted DAS or endotracheal intubation GA. Randomization will be stratified by study center and hypertension status, using permuted blocks of sizes 2 and 4. The major exclusion criterion is severe cardiopulmonary disease. The primary outcome is a composite of SRAEs, including hypoxemia, hypotension, hypertension, laryngospasm, or bronchospasm. Secondary outcomes include escalation of respiratory support, tachycardia, bradycardia, reflux, recovery time, postoperative recovery quality (QoR-15), postoperative nausea and vomiting (PONV), cognitive function, perioperative respiratory failure or acute respiratory distress syndrome (ARDS), patient and endoscopist satisfaction, and length of hospital stay. All analyses will follow a modified intention-to-treat approach.

ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee of Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (2025-0780). Written informed consent will be obtained from all participants prior to enrollment. The findings of this trial will be disseminated through publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: Clinical Trial Registry (NCT07017283).