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Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery

NCT07026162 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-07-29

No results posted yet for this study

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

Interventions

DRUG

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.

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.

Sponsors & Collaborators

  • YanYing Xiao

    lead OTHER

Principal Investigators

  • Xiao · Second Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-21
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07026162 on ClinicalTrials.gov