Overview
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.
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:
- Randomization: Computer-generated 1:1 allocation via sealed envelopes
- 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
- Control: Active comparator (sufentanil) reflecting current standard practice.
Technical Methodology：
- 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).
- 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.
- 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).
Eligibility
Inclusion criteria:
- Elective gynecological laparoscopic surgery;
- Age 18-65 years;
- ASA physical status I-III;
- Body mass index (BMI) 18-30 kg/m².
Exclusion criteria:
- Severe dysfunction of major organs such as the heart, lungs, or brain;
- History of allergy to opioid drugs, propofol, soybeans, or eggs;
- Recent use of sedatives, analgesics, or monoamine oxidase inhibitors;
- History of alcohol abuse;
- Obstructive sleep apnea syndrome;
- Difficult airway;
- Psychiatric or neurological disorders; communication disorders;
- Women who are lactating or pregnant.
Withdrawal criteria:
- Subject requests withdrawal or withdraws voluntarily;
- Change in surgical method requiring combined gastrointestinal surgery;
- Occurrence of allergy to the investigational drug or life-threatening complications;
- Reoperation within 48 hours postoperatively due to bleeding or other factors.