RecruitingPhase 4NCT07026162

Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery

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


Sponsor

YanYing Xiao

Enrollment

96 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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

Exclusion Criteria13

  • 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.

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Interventions

DRUGOliceridine

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.

DRUGSufentanil

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.


Locations(1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

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NCT07026162


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