Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery

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).

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.