Comparison of Postoperative Recovery Quality and Safety Between Anricofen Combined With Ciprofol and Sufentanil Combined With Ciprofol for Non-intubated Anesthesia During ERCP

This study aims to compare postoperative recovery quality and safety between anricofen combined with ciprofol and sufentanil combined with ciprofol in patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) under non-intubated anesthesia. This is a single-center, prospective, randomized, controlled study involving patients aged 18-80 years who are scheduled for elective ERCP. A total of 180 participants are planned to be enrolled and randomly assigned in a 1:1 ratio to two groups. Participants in the anricofen group will receive intravenous anricofen (HSK21542) at a dose of 1 μg/kg before ciprofol induction. Participants in the sufentanil group will receive intravenous sufentanil at a dose of 0.1 μg/kg before ciprofol induction. Both groups will receive ciprofol for anesthesia induction and maintenance. The primary outcome is the total Quality of Recovery-15 (QoR-15) score at 24 hours after the procedure. Secondary outcomes include postoperative pain scores at different time points, total ciprofol consumption, recovery time, post-anesthesia care unit stay, respiratory and hemodynamic adverse events, postoperative nausea and vomiting, and serious adverse events. The study is expected to provide clinical evidence on the postoperative recovery quality and safety of these two analgesic regimens for patients undergoing ERCP under non-intubated anesthesia.

\*\*Inclusion Criteria:\*\* 1. Aged 18 to 80 years; 2. American Society of Anesthesiologists (ASA) physical status I to III; 3. Patients scheduled to undergo elective endoscopic retrograde cholangiopancreatography (ERCP). \*\*Exclusion Criteria:\*\* 1. Pregnancy or lactation; 2. Obstructive sleep apnea (OSA); 3. Long-term use of analgesics or psychotropic drugs, or a history of drug abuse; 4. Coagulation dysfunction, bleeding tendency, or current anticoagulant therapy; 5. Allergy to any of the study drugs; 6. Severe cardiac, hepatic, renal, or other major organ diseases; 7. Mental or cognitive impairment that prevents cooperation with the assessment; 8. Inability to comply with the study protocol or complete follow-up; 9. Requirement for tracheal intubation, postoperative transfer to the intensive care unit (ICU), or postoperative pancreatitis.