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.
Xuanwu Hospital, Beijing
174 participants
Mar 25, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Scheduled for elective CPA region surgery with planned PCIA.
- Age 18-65 years.
- ASA physical status I-III.
- Provides written informed consent.
Exclusion Criteria5
- Opioid tolerance (taking opioids ≥1 week, equivalent to oral morphine ≥50 mg/day or oxycodone ≥30 mg/day).
- Severe cardiopulmonary, hepatic, renal, vascular, neurological, hematological, gastrointestinal, or endocrine diseases.
- Postoperative ICU admission with tracheal intubation.
- BMI ≤18.5 or ≥30 kg/m².
- Participation in another clinical trial within 3 months prior to screening.
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Interventions
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.
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.
Locations(1)
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NCT07479446