Prospective Randomized Double Blind Study of Intraoperative Dexmedetomidine and Postoperative Pain Control in Patients Undergoing Multi-level Thoraco-lumbar Spine Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Opiate consumption
研究概览
简要总结
The investigators will conduct a prospective randomized double blind study comparing methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in two randomized groups. The investigators plan to document the intraoperative opioid requirements, time to first dose of opioids postoperatively and total opioid consumption in the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will be assessed.
详细描述
Patients presenting for thoracic and/or lumbar spine surgery with neuromonitoring (MEP/SSEP/EMG)will be recruited. Standard anesthesia monitoring will be performed. Randomized to a placebo or dexmedetomidine arm. Both groups will receive methadone 0.2 mg/kg ideal weight after induction of anesthesia.
The placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure.
Intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia team.
Upon closure the study drug will be terminated. Patients will be followed up for 72 hours after surgery. Total opiate consumption and visual analogue scale ratings will be documented.
Intra and postoperative inotrope/pressor requirements will be recorded.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-80 years of age
- •Elective multi-level thoracic and/or lumbar spine surgery requiring SSEP, EMG or MEP monitoring
排除标准
- •Emergency spine surgery
- •Age < 18 years
- •Pregnant patients
- •Advanced heart block: Mobitz type II block or atrio-ventricular dissociation in a previous EKG.
- •Any individual with stage 4 or greater chronic kidney disease (eGFR< 30 ml/min) and/or requiring dialysis or liver failure defined as a history of cirrhosis or fulminant hepatic failure
- •Any individuals on preoperative methadone therapy
- •Preoperative dexmedetomidine use
- •Preoperative systolic hypertension defined by a systolic blood pressure greater than 150 mmHg in the surgical admission suite
- •Enrolled in another study within 30 days
研究组 & 干预措施
Methadone and dexmedetomidine
Standard American Society of Anesthesiology monitors. Midazolam 1-2 mg for pre-operative sedation. Lidocaine 0.5-1 mg/kg with induction. Propofol 1-2 mg/kg with induction. Fentanyl 0.5-1 mcg/kg with induction. Rocuronium 0.5 -1 mg/kg with induction. Total intravenous anesthesia with propofol for maintainence of anesthesia. Titrated to maintain BIS (bispectral index) between 30-60.
Methadone 0.2 mg/kg ideal body weight and dexmedetomidine 1 mcg/kg load over 20 minutes followed by a continuous infusion of 0.5 mcg/kg/h for the duration of the procedure.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Opiate consumption
时间窗: 72 hours post surgery
We will measure total opiate consumption 72 hours post surgery
次要结局
- Pain Scores on the Visual Analog Scale(72 hours)
研究者
Bhiken I. Naik, MD
Assistant Professor, Anesthesiology
University of Virginia