Oliceridine to reduce nausea and vomiting after gynecologic laparoscopy

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

This trial will test whether oliceridine causes less postoperative nausea and vomiting than sufentanil in adults having gynecologic laparoscopic surgery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Second Xiangya Hospital of Central South University (other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT07026162 on ClinicalTrials.gov

What this trial studies

This is a randomized, triple‑blind, parallel‑controlled Phase 4 trial comparing intravenous oliceridine versus sufentanil for anesthesia and postoperative analgesia in elective gynecologic laparoscopy. Patients are randomly assigned 1:1 with identical drug preparation and blinded teams, receive standardized TIVA protocols and patient‑controlled analgesia, and are monitored with BIS and routine vital signs. The primary outcome is the incidence of postoperative nausea and vomiting (PONV) with safety and opioid‑related adverse events tracked up to 48 hours postoperatively. Rescue antiemetics and analgesics are predefined and used per protocol to manage symptoms.

Who should consider this trial

Good fit: Adults aged 18–65 years with ASA physical status I–III and BMI 18–30 kg/m² scheduled for elective gynecologic laparoscopic surgery who can comply with perioperative protocol and 48‑hour follow‑up.

Not a fit: Patients with severe organ dysfunction, obstructive sleep apnea, opioid allergy, recent use of contraindicated medications, pregnancy or lactation, or other listed exclusion criteria are not likely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, oliceridine could lower rates of postoperative nausea and vomiting and provide comparable pain control with fewer opioid‑related side effects for patients after gynecologic laparoscopy.

How similar studies have performed: Previous trials of oliceridine in postoperative settings have shown similar analgesia and a potentially improved respiratory and adverse event profile compared with conventional opioids, but specific data on PONV in gynecologic laparoscopy are limited.

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.

Where this trial is running

Changsha, Hunan

• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (RECRUITING)

Study contacts

• Principal investigator: Xiao — Second Xiangya Hospital of Central South University
• Study coordinator: Yanying Xiao, Doctor

Conditions: Gynecologic Surgical Procedures, Postoperative Nausea and Vomiting, Laparoscopy, postoperative nausea and vomiting, Oliceridine