NCT07479446

Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery

Comparative Study of Oliceridine Versus Sufentanil for Patient-Controlled Intravenous Analgesia in Improving Postoperative Nausea in Patients Undergoing Cerebellopontine Angle Region Surgery.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• PONV
• Cerebellopontine Angle Tumor
• Microvascular Decompression Surgery
• Postoperative Analgesia

Interventions

Type	Name	Description
DRUG	Oliceridine	Loading dose of 1.5 mg IV at dural closure. PCIA pump: Oliceridine 0.4 mg/kg diluted to 100 ml with normal saline. Settings: background infusion 1 ml/h, bolus dose 0.5 ml, lockout time 6 min, maximum 27 mg/24h. Duration: 48h.
DRUG	Sufentanil	Loading dose of 7.5 mcg IV at dural closure. PCIA pump: Sufentanil 2 mcg/kg diluted to 100 ml with normal saline. Settings: background infusion 1 ml/h, bolus dose 0.5 ml, lockout time 6 min. Duration: 48h.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-08-31
• Completion: 2027-09-30
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: China