JMIR Publications

ABSTRACT

Background:

Hysteroscopy, the gold standard for diagnosing and treating intrauterine pathologies, shows substantial growth 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. This trial aims to determine whether oliceridine enhances early recovery quality while reducing opioid-related complications compared to sufentanil in patients undergoing hysteroscopy under general anesthesia.

Objective:

This study aims to evaluate whether oliceridine, compared with sufentanil, provides non-inferior intraoperative analgesia while demonstrating superior postoperative recovery quality and reduced opioid-related complications 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 QoR-15 scale at 24 hours postoperatively, 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 PACU, postoperative extubation time, opioid-related adverse events within 24 hours, and VAS pain scores at 30 minutes, 4 hours, 8 hours, and 24 hours post-extubation.

Results:

This study received approval from the Medical Ethics Committee of Deyang People’s Hospital on April 16, 2025 (approval no. 2025-03-009-K01). Participant recruitment is currently in progress and is anticipated to be completed by the end of 2025. Data analysis, manuscript preparation, and submission for publication are expected to take place throughout the first quarter of 2026.

Conclusions:

This randomized controlled trial is designed to evaluate early recovery quality following hysteroscopy under general anesthesia. We aim to investigate whether oliceridine demonstrates an advantage over sufentanil in enhancing postoperative recovery while mitigating opioid-related adverse effects. Although conducted at a single center and lacking long-term perioperative safety data for oliceridine, this study will provide foundational evidence to inform future clinical investigations. Clinical Trial: This study was prospectively registered at the Chinese Clinical Trial Registry (Registration number:ChiCTR2500104024; Date: 10 Jun 2025).