Actively Recruiting
Effects of Oliceridine Versus Sufentanil on Postoperative Nausea and Vomiting After Gynecological Laparoscopic Surgery A Randomized, Double-Blind Controlled Trial
Led by YanYing Xiao · Updated on 2025-07-29
96
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the impact of the painkiller Oliceridine on reducing postoperative nausea and vomiting (PONV) in women undergoing gynecological laparoscopic surgery. It compares Oliceridine with the commonly used analgesic sufentanil and assesses any opioid-related side effects. The study is randomized, double-blind, and controlled, aiming to clarify whether Oliceridine offers advantages in managing PONV and its safety profile. Participants receive anesthesia and pain control with either Oliceridine or sufentanil. Both drugs are given during surgery and afterwards through patient-controlled analgesia pumps. Standard anesthesia drugs like midazolam, propofol, cisatracurium, and remifentanil are used along with the study drugs. The study includes careful dosing, monitoring anesthesia depth, and managing blood pressure to ensure safety. Patients are monitored from the time they wake up until 48 hours after surgery for nausea, vomiting, pain levels, sedation, sleep quality, and recovery measures. Researchers record vital signs during surgery and track use of rescue medications. They also observe bowel function and time spent in the recovery unit. The study lasts through surgery and at least 48 hours of follow-up, aiming to provide detailed data on nausea, vomiting, pain, and overall recovery quality.
CONDITIONS
Brief Title
Oliceridine on Postoperative Nausea and Vomiting in Gynecological Laparoscopic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective gynecological laparoscopic surgery
- Age between 18 and 65 years
- ASA physical status I to III
- Body mass index (BMI) between 18 and 30 kg/m²
You will not qualify if you...
- Severe dysfunction of major organs such as heart, lungs, or brain
- 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 or communication difficulties
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo gynecological laparoscopic surgery under general anesthesia with either Oliceridine or Sufentanil. Anesthesia induction and maintenance are provided during the surgery, followed by postoperative pain management through a patient-controlled analgesia (PCA) system using the assigned drug.
1 visit (in-person surgery and immediate recovery)
Duration - Up to 3 days post-surgery
Participants are monitored for postoperative nausea and vomiting, pain levels, sedation, sleep quality, recovery quality, bowel function, and safety outcomes for up to 48 hours after surgery. Additional assessments for recovery quality continue up to 3 days postoperatively.
Multiple assessments up to 48 hours postoperatively, including at awakening, PACU discharge, 2, 6, 12, 24, and 48 hours; follow-up visits on postoperative days 1 and 3
Trial Site Locations
Total: 1 location
1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
Research Team
Y
Yanying Xiao, Doctor
Y
Yaping WANG, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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