Effect of Postoperative Analgesia of Oliceridine Fumarate for Gastrointestinal Function Recovery in Patients Undergoing Lumbar Spine Surgery:A Prospective, Multicenter, Double-blind,Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 428
- 试验地点
- 1
- 主要终点
- Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours
研究概览
简要总结
Osemitidine fumarate is a novel G protein-biased ligand μ-opioid receptor agonist. Previous studies have confirmed its potent analgesic effects and safety: compared with morphine, it reduces respiratory depression and gastrointestinal dysfunction. This study aims to evaluate the effects of osemitidine on postoperative gastrointestinal function recovery and pain in patients undergoing lumbar spine surgery through a multicenter, double-blind, randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 75 years old;
- •Patients undergoing lumbar surgery under general anesthesia (within 3 segments) and expected to receive postoperative patient-controlled analgesia;
- •ASA classification I-III;
- •BMI between 18 and 30 kg/m²;
- •Informed consent obtained from the patient.
排除标准
- •Use of any painkillers within 3 days before surgery; or long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), defined as: within 3 months before surgery, use of NSAIDs daily for more than 2 consecutive weeks;
- •Presence of intestinal obstruction or suspicious symptoms: nausea and vomiting, abdominal bloating and pain, cessation of gas or bowel movements within the past two weeks, imaging suggesting intestinal dilation, or large amounts of air-fluid levels;
- •Patients with severe liver dysfunction (based on Child-Pugh classification, grade C);
- •History of or planned gastrointestinal surgery;
- •Patients allergic to the study drug;
- •Pregnant or breastfeeding patients;
- •QTcF abnormalities, males >450 ms, females >470 ms;
- •Participation in other drug trials within the past 30 days;
- •Long-term use of opioids (defined as: within 12 months before surgery, use for more than 1 month, more than 3 days per week, with daily doses exceeding 15 mg morphine equivalent);
- •Pre-existing neurological or psychiatric disorders: such as epilepsy, depression, schizophrenia, etc.;
- •Patients deemed unsuitable for this study by the investigator.
研究组 & 干预措施
Oliceridine Group
Oliceridine Patient-Controlled Analgesia Pump After Lumbar Spine Surgery
干预措施: Oiceridine (Drug)
Sufentanil Group
Sufentanil Patient-Controlled Analgesia Pump After Lumbar Spine Surgery
干预措施: Sufentanil (Drug)
结局指标
主要结局
Proportion of patients reaching the GI-3 composite endpoint within postoperative 24 hours
时间窗: postoperative 24 hours
Proportion of patients reaching the GI-3 composite endpoint (tolerating solid food and passing gas/bowel movement) within postoperative 24 hours
次要结局
- Proportion of patients reaching the GI-3 composite endpoint within postoperative 48 hours(postoperative 48 hours)
- GI-3(postoperative 48 hours)
- IFEED score(postoperative 24 and 48 hours)
- Postoperative SPID(postoperative 24 and 48 hours)
- Opioid consumption(postoperative 24 and 48 hours)
- remedial analgesia(postoperative 48 hours)