Effects of Oliceridine Versus Sufentanil on Postoperative Recovery Quality During Hysteroscopy Under Laryngeal Mask Airway Anesthesia: Protocol for a Single-Blind and Randomized Controlled Trial.
YuHang Shou, JianSheng Luo, XianJie Zhang, WenHu Zhai, Jia Han
Abstract
Open AccessBACKGROUND: Hysteroscopy, the gold standard for diagnosing and treating intrauterine pathologies, has shown substantial increase in its adoption in clinical practice. Nevertheless, early postoperative pain and opioid-related adverse effects remain critical determinants of recovery quality. Oliceridine-a novel G protein-biased μ-opioid receptor agonist-demonstrates an improved therapeutic range over conventional opioids in preliminary studies. OBJECTIVE: This study aims to evaluate whether oliceridine enhances recovery quality while reducing opioid-related complications compared to sufentanil in patients undergoing hysteroscopy under general anesthesia. METHODS: This single-center randomized controlled trial will enroll 120 patients undergoing hysteroscopy under general anesthesia with 1:1 randomization to sufentanil- or oliceridine-based analgesia. The primary outcome is early recovery quality assessed by the 15-item Quality of Recovery scale at 24 hours after the surgery, while secondary outcomes include hemodynamic fluctuations during induction, total intraoperative opioid consumption and supplemental bolus frequency, proportion requiring vasoactive agents, incidence of respiratory depression in postanesthesia care unit, postoperative extubation time, opioid-related adverse events within 24 hours, and Visual Analog Scale pain scores at 30 minutes, 4 hours, 8 hours, and 24 hours postextubation. RESULTS: This study received approval from the Medical Ethics Committee of Deyang People's Hospital, Deyang, China, on April 16, 2025 (approval 2025-03-009-K01). Participant recruitment is anticipated to be completed by December 2025. Data analysis, manuscript preparation, and submission for publication are expected to be completed by February 2026. CONCLUSIONS: The successful completion of this trial will generate evidence regarding whether oliceridine enhances recovery quality while reducing opioid-related complications compared to sufentanil in patients undergoing hysteroscopy under general anesthesia. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2500104024; https://www.chictr.org.cn/showproj.html?proj=275501. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/84521.