Comparative Study of Oliceridine Versus Sufentanil for Patient-Controlled Intravenous Analgesia in Improving Postoperative Nausea in Patients Undergoing Cerebellopontine Angle Region Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Nausea
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for elective CPA region surgery with planned PCIA.
- •Age 18-65 years.
- •ASA physical status I-III.
- •Provides written informed consent.
排除标准
- •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.
研究组 & 干预措施
Sufentanil
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.
干预措施: Sufentanil (Drug)
Oliceridine
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.
干预措施: Oliceridine (Drug)
结局指标
主要结局
Incidence of Postoperative Nausea
时间窗: 6 to 48 hours after surgery
Defined as the subjective feeling of wanting to vomit, lasting ≥5 minutes.
次要结局
- Postoperative Pain Intensity(Within 48 hours after surgery)
研究者
Wang Tianlong
Dr.
Xuanwu Hospital, Beijing