Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery

NCT07026162 | Recruiting Phase 4 DMC

• 1 other identifier: LYEC2024-0425
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Laparoscopy; Gynecologic Surgical Procedures; postoperative nausea and vomiting; Oliceridine

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative nausea and vomiting(PONV)

  PONV will be assessed within 48 hours postoperatively in the ward by a blinded investigator. Subjects are required to use the simplified PONV impact scale to report whether any PONV events occurred in the past 48 hours and to provide a rating. (Q1. Have you experienced vomiting or symptoms of vomiting? If yes, how many episodes in total? Under what circumstances did it occur? Was any medication administered for treatment? Q2. Have you experienced nausea? If yes, did the sensation of nausea affect your daily activities? Was any medication administered for treatment?) Mild PONV is defined as mild nausea or a single vomiting episode caused by water or physical activity. Moderate PONV includes two vomiting episodes or significant nausea needing rescue therapy. Severe PONV is more than two vomiting episodes or requiring multiple doses of rescue therapy. Absence of symptoms requiring treatment is considered complete remission.

  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 (9)

• Incidence of postoperative vomiting (POV) postoperative 48 hours

  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.

• Rescue antiemetic medications

  From awakening to 48 hours postoperatively

• Postoperative Visual Analog Scale (VAS) score

  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.

• Ramsay sedation score

  Postoperative 2 hours

• Sleep quality score

  At the night of the surgery day, Day 0

Other Outcomes (1)

• Patient demographic characteristics

  Baseline, preoperative

Study Arms (2)

Oliceridine group

EXPERIMENTAL

Anesthesia and analgesia with Oliceridine

Drug: Oliceridine

Sufentanil group

OTHER

Anesthesia and analgesia with sufentanil

Drug: Sufentanil

Interventions

Oliceridine 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.

Also known as: TRV130, olinvyk

Oliceridine group

Sufentanil 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.

Sufentanil group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• YanYing Xiao: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

((3-methoxythiophen-2-yl)methyl)((2-(9-(pyridin-2-yl)-6-oxaspiro(4.5)decan-9-yl)ethyl))amine; Sufentanil

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiao

  Second Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanying Xiao, Doctor

CONTACT

+8613467609491; xiaoyanying192@csu.edu.cn

Yaping WANG, Doctor

CONTACT

+8613607314476; wangyaping6568@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of the Department of Anesthesiology, the Second Xiangya Hospital, Central south University

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 18, 2025
• Study Start: July 21, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD will be available when the last participant's follow-up is completed, and there is no time limit for its usage.
• Access Criteria: Contact the author at any time.

Locations

CN (1)