NCT07026162

Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery

Series Study on the Application of G Protein-Biased Receptor Agonist Oliceridine in Gynecological Surgery (2)：Effects of Oliceridine Versus Sufentanil on Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: YanYing Xiao · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to evaluate the impact of the analgesic Oliceridine on postoperative nausea and vomiting (PONV) following gynecological laparoscopic surgery. It will also assess the safety profile of Oliceridine. The trial seeks to address the following key questions: Can Oliceridine reduce the incidence of postoperative nausea and vomiting (PONV) in gynecological laparoscopic surgery? Does the incidence of PONV differ between patients receiving Oliceridine and those receiving the commonly used analgesic sufentanil in gynecological laparoscopic surgery? Are there any opioid-related adverse reactions in gynecological laparoscopic surgery patients using Oliceridine? Participants will: Receive Oliceridine or sufentanil for anesthesia induction, maintenance, and postoperative pain management. Vital signs during surgery and the occurrence of postoperative nausea and vomiting will be recorded. Be followed up for at least 48 hours.

Detailed description

Study Design: This randomized, double-blind, parallel-controlled trial compares oliceridine versus sufentanil for anesthesia/analgesia in gynecologic laparoscopy at Second Xiangya Hospital. The study features: 1. Randomization: Computer-generated 1:1 allocation via sealed envelopes 2. Blinding: Triple-blinding (participants, clinicians, outcome assessors) maintained through: Identical drug preparations (volume/appearance-matched);Separation between anesthesia nurses preparing drugs and clinical/research teams 3. Control: Active comparator (sufentanil) reflecting current standard practice. Technical Methodology： 1. Anesthesia Protocol: Standardized induction with midazolam (0.05-0.10 mg/kg), study drug (sufentanil 0.3 μg/kg vs oliceridine 0.06 mg/kg), propofol (1.5-2.0 mg/kg), and cisatracurium (0.2-0.3 mg/kg). Maintenance via TIVA: propofol (4-10 mg/kg/h) + remifentanil (0.1-0.2 μg/kg/min). Pre-incision/closure boluses: Study drug dosed per group (sufentanil 0.1-0.2 μg/kg vs oliceridine 0.02-0.04 mg/kg). 2. Analgesia Management: PCA pump configuration: Sufentanil group: 2 μg/kg in 100 mL NS; Oliceridine group: 0.4 mg/kg in 100 mL NS; Fixed adjuncts: ondansetron 8 mg + dexamethasone 10 mg.Demand dose: 2 mL (lockout 10 min), max 10 mL/h. 3. Rescue Protocols: Analgesia: Sufentanil 5 μg or oliceridine 0.2 mg IV PRN; PONV: Ondansetron 4 mg + dexamethasone 5 mg; haloperidol 1 mg if refractory. Quality Assurance Measures: Anesthesia depth monitoring: BIS-guided propofol titration; Hemodynamic stability: Protocolized management of hypotension (defined as MAP \<65 mmHg); Data validation: 10% random audit of time-stamped outcomes (PACU discharge, bowel recovery). Pharmacokinetic Considerations: Oliceridine dosing based on morphine equivalence (1mg ≈ 5mg morphine); Adjusted intraoperative dosing to account for context-sensitive half-time differences vs sufentanil. Statistical Approach: Sample size: Powered for PONV incidence difference (α=0.05, β=0.2); Analysis: ITT principle with sensitivity analysis for protocol deviations; Covariate adjustment: Stratification by Apfel risk factors (female sex, non-smoking, PONV history, opioid use).

Conditions

• Gynecologic Surgical Procedures
• Postoperative Nausea and Vomiting (PONV)
• Laparoscopy

Interventions

Type	Name	Description
DRUG	Oliceridine	For gynecological laparoscopic surgery, general anesthesia was induced with Oliceridine at a dose of 0.06 mg/kg (Yichang Renfu Pharmaceutical Co., Ltd., China). Intraoperative analgesia was administered with a total dose of Oliceridine ranging from 0.1 to 0.15 mg/kg. Postoperatively, Oliceridine was administered through a patient-controlled analgesia (PCA) system.
DRUG	Sufentanil	For gynecological laparoscopic surgery, general anesthesia was induced with Sufentanil at a dose of 0.3 µg/kg (Yichang Renfu Pharmaceutical Co., Ltd., China). Intraoperative analgesia was provided with a total dose of Oliceridine ranging from 0.5 to 0.8 µg/kg. Postoperatively, Sufentanil was administered through a patient-controlled analgesia (PCA) system.

Timeline

• Start date: 2025-07-21
• Primary completion: 2025-12-31
• Completion: 2026-01-31
• First posted: 2025-06-18
• Last updated: 2025-07-29

Locations

1 site across 1 country: China