drugset / Trial / NCT07479446

Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery

NCT07479446

Recruiting 174 enrolled Xuanwu Hospital, Beijing
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This single-center, double-blind, randomized controlled trial aims to determine whether oliceridine for patient-controlled intravenous analgesia (PCIA) can significantly reduce the incidence of postoperative nausea, an opioid-related adverse reaction, compared to sufentanil PCIA in patients undergoing cerebellopontine angle (CPA) region surgery. A secondary objective is to compare the postoperative analgesic effects between the two drugs. The study plans to enroll 174 patients (with a calculated sample size of 164 plus 5% for attrition). The primary outcome is the incidence of nausea within 6-48 hours postoperatively. Secondary outcomes include pain scores at rest and during movement within 48 hours, and other exploratory outcomes such as vomiting incidence, time to first flatus/defecation, and gastrointestinal function scores.

Timeline

Start
2026-03-25
Primary completion
2027-08-31
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Oliceridine Other / unclassified 0.4 mg/kg Intravenous
Comparator Sufentanil Other / unclassified 2 ug/kg Intravenous