Clinical trial NCT07026162: Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Gynecologic Surgical Procedures
Postoperative Nausea and Vomiting (PONV)
Laparoscopy
Keywords: Laparoscopy
Gynecologic Surgical Procedures
postoperative nausea and vomiting
Oliceridine
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion criteria:

1. Elective gynecological laparoscopic surgery;
2. Age 18-65 years;
3. ASA physical status I-III;
4. Body mass index (BMI) 18-30 kg/m².

Exclusion criteria:

1. Severe dysfunction of major organs such as the heart, lungs, or brain;
2. History of allergy to opioid drugs, propofol, soybeans, or eggs;
3. Recent use of sedatives, analgesics, or monoamine oxidase inhibitors;
4. History of alcohol abuse;
5. Obstructive sleep apnea syndrome;
6. Difficult airway;
7. Psychiatric or neurological disorders; communication disorders;
8. Women who are lactating or pregnant.

Withdrawal criteria:

1. Subject requests withdrawal or withdraws voluntarily;
2. Change in surgical method requiring combined gastrointestinal surgery;
3. Occurrence of allergy to the investigational drug or life-threatening complications;
4. Reoperation within 48 hours postoperatively due to bleeding or other factors.

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting(PONV)
timeFrame: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
Secondary outcomes:
measure: Incidence of postoperative vomiting (POV) postoperative 48 hours
timeFrame: From the time of awakening to 48 hours postoperatively. Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
measure: Rescue antiemetic medications
timeFrame: From awakening to 48 hours postoperatively
measure: Postoperative Visual Analog Scale (VAS) score
timeFrame: From the time of awakening to 48 hours postoperatively . Specially, at the moment of awakening, at the time of leaving the PACU, postoperative 2 hours, 6 hours , 12 hours, 24 hours and 48 hours.
measure: Ramsay sedation score
timeFrame: Postoperative 2 hours
measure: Sleep quality score
timeFrame: At the night of the surgery day, Day 0
measure: Quality of Recovery-15 (QOR-15) score
timeFrame: Preoperative, postoperative day 1, and postoperative day 3, respectively
measure: The time of the first postoperative bowel gas passage
timeFrame: From end of surgery until first postoperative passing of gas, assessed up to 72 hours.
measure: Time staying in the PACU
timeFrame: From PACU arrival until discharge, assessed up to 6 hours.
measure: Intraoperative hypotension
timeFrame: From anesthesia induction until PACU discharge, assessed up to 6 hours.
Other outcomes:
measure: Patient demographic characteristics
timeFrame: Baseline, preoperative
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Xiao
role: PRINCIPAL_INVESTIGATOR
References: