Effect of Opioid-Sparing Anesthesia on Postoperative Opioid Consumption and Pain in Spine Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
研究概览
简要总结
The goal of this clinical trial is to learn if an anesthesia management strategy called opioid-sparing anesthesia could help reduce postoperative opioid consumption, pain intensity and enhance recovery in elderly patients undergoing spine surgery. The main questions it aims to answer are:
Does opioid-sparing anesthesia reduce postoperative opioid consumption?
Dose opioid-sparing anesthesia improve postoperative pain and enhance recovery?
Researchers will compare opioid-sparing anesthesia to routine anesthesia which is used most common in clinical practice to see if opioid-sparing anesthesia lead to fewer postoperative opioid consumption and better pain and recovery outcomes.
Participants will randomly assigned to one of two groups. One group will receive opioid-sparing anesthesia management , while the other group will receive routine anesthesia management during general anesthesia.
Participants will provide two rectal swab samples for analysis, complete five questionnaires once preoperatively, and then complete five questionnaires daily for three days postoperatively.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 65 years
- •Undergoing multilevel level (≥2 levels) spine surgery under general anesthesia
- •Able to provide written informed consent
排除标准
- •Diagnosed with severe cognitive impairment or psychiatric disorders that impair participation or communication
- •Pregnant or breastfeeding
- •Patients with contraindications to any of the medications in the study protocol (unstable angina, recent myocardial infarction, cerebral or aortic aneurysms, increased intracranial pressure, increased intraocular pressure, psychosis or schizophrenia, pheochromocytoma, epilepsy, second- or third-degree atrioventricular block, bradycardia (heart rate < 50bpm), liver failure, hypotension (systolic BP <80 mmHg))
- •Drug or alcohol abuse
- •Refuse to participate
研究组 & 干预措施
Group 1：Opioid-Sparing Anesthesia
Participants assigned to Group 1 will receive opioid-sparing anesthesia strategy. Continuous intravenous infusion of ketamine (5 μg/kg/min) and dexmedetomidine (0.6 μg/kg/h) will be initiated from induction and maintained until one hour before the anticipated end of surgery. If needed during surgery, rescue analgesia with dexmedetomidine (0.4 μg/kg, i.v.) or ketamine (5 mg, i.v.) may be administered as clinically indicated.
干预措施: Opioid-Sparing Protocol (Drug)
Group 2：Routine Anesthesia
Participants assigned to Group 2 will receive routine anesthesia management. During induction, fentanyl 100 μg will be administered intravenously. If needed during surgery, rescue analgesia with hydromorphone may be administered as clinically indicated.
干预措施: Routine anesthesia protocol (Drug)
研究者
Jingping Wang, MD, Ph.D.
Associate Professor, Harvard Medical School
Massachusetts General Hospital