Oliceridine Versus Sufentanil for Postoperative Nausea in Cerebellopontine Angle Surgery

N/ANot Yet RecruitingNCT07479446

Xuanwu Hospital, Beijing174 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

174

Conditions

PONV Cerebellopontine Angle Tumor Microvascular Decompression Surgery

Interventions

OliceridineDRUG

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.

SufentanilDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of Postoperative Nausea

Defined as the subjective feeling of wanting to vomit, lasting ≥5 minutes.

Time frame: 6 to 48 hours after surgery

Secondary Outcomes

Postoperative Pain Intensity

Assessed using the Verbal Rating Scale (VRS, 0-10) at rest and during movement.

Time frame: Within 48 hours after surgery