Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery

NCT ID: NCT07026162

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2026-01-31

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Oliceridine group

Anesthesia and analgesia with Oliceridine

Group Type: EXPERIMENTAL

Oliceridine

Intervention Type: DRUG

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.

Sufentanil group

Anesthesia and analgesia with sufentanil

Group Type: OTHER

Sufentanil

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

TRV130; olinvyk

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YanYing Xiao

OTHER

Sponsor Role: lead

Responsible Party

YanYing Xiao

Associate Professor of the Department of Anesthesiology, the Second Xiangya Hospital, Central south University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xiao

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital of Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanying Xiao, Doctor

Role: CONTACT

xiaoyanying192@csu.edu.cn

+8613467609491

Yaping WANG, Doctor

Role: CONTACT

wangyaping6568@csu.edu.cn

+8613607314476

Facility Contacts

Yibo Hu

Role: primary

xy2gcphyb@163.com

+860731-85292476

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

LYEC2024-0425

Identifier Type: -

Identifier Source: org_study_id