NCT07026162 Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery
| NCT ID | NCT07026162 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | YanYing Xiao |
| Condition | Gynecologic Surgical Procedures |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-07-21 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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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.
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.