PONV, Cerebellopontine Angle Tumor, Microvascular Decompression Surgery, Postoperative Analgesia
Conditions
Brief 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.
Interventions
DRUGOliceridine
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.
DRUGSufentanil
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.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Nausea | 6 to 48 hours after surgery | Defined as the subjective feeling of wanting to vomit, lasting ≥5 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | Within 48 hours after surgery | Assessed using the Verbal Rating Scale (VRS, 0-10) at rest and during movement. |
Countries
China
Contacts
CONTACTWei Xiao, Dr.
Outcome results
None listed