Comparison of oliceridine and fentanyl intraoperative analgesia on postoperative nausea and vomiting in female patients undergoing laparoscopic cholecystectomy: study protocol for a randomized, double-blind, controlled trial.

BACKGROUND: Postoperative nausea and vomiting (PONV) is significantly associated with intraoperative opioid use. Oliceridine, a μ-opioid receptor agonist with G protein bias, exhibits fewer opioid-related adverse events (ORAEs) than morphine. This study aims to evaluate the effect of oliceridine versus fentanyl on the incidence of PONV in female patients undergoing laparoscopic cholecystectomy. METHODS: This is a single-center, randomized controlled trial conducted at Changshu No. 2 People's Hospital in China. A total of 228 female patients scheduled for elective laparoscopic cholecystectomy will be enrolled in this trial and randomly assigned in a 1:1 ratio to receive either oliceridine (Group O) or fentanyl (Group F) for intraoperative analgesia. The primary endpoint is the incidence of PONV during the first 24 h postoperatively. The secondary endpoints consist of the severity and timing of the initial occurrence of PONV, the requirement for antiemetics and rescue analgesia, postoperative pain assessments, time to first flatus and extubation, postoperative sleep quality, intraoperative consumption of anesthetics and vasopressors, and perioperative adverse effects. DISCUSSION: We hypothesize that oliceridine may offer effective analgesia and a lower incidence of PONV than fentanyl in intraoperative pain management for this high-risk group. The findings may provide valuable insights into optimizing perioperative pain management strategies and enhancing patient recovery. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2500096538. Registered on 26 January 2025.