Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebellopontine Angle Tumor | Cerebellopontine Angle Neoplasm | ALIAS | 0.90 |
| Microvascular Decompression Surgery | — | UNRESOLVED | — |
| PONV | — | UNRESOLVED | — |
| Postoperative Analgesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oliceridine | Drug | — | UNRESOLVED |
| Sufentanil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oliceridine
- description
- 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.
- interventionNames
- Drug: Oliceridine
- type
- ACTIVE_COMPARATOR
- label
- Sufentanil
- description
- 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.
- interventionNames
- Drug: Sufentanil
Primary outcomes (1)
- measure
- Incidence of Postoperative Nausea
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available