Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery
NCT07479446
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 Criteria: * Scheduled for elective CPA region surgery with planned PCIA. * Age 18-65 years. * ASA physical status I-III. * Provides written informed consent. Exclusion Criteria: * 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.
Conditions5
Interventions2
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NCT07479446