A Double-Masked Placebo Controlled Clinical Trial of the Postoperative Opioid Sparing Effects of Intraoperative Dexmedetomidine Infusion for Thoracic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 333
- 试验地点
- 4
- 主要终点
- Total Opioid Administered
研究概览
简要总结
The purpose of this study is to see if the drug, Dexmedetomidine (also known as Precedex), can reduce pain for patients having Thoracic Surgery and therefore reduce the amount of opioid drug needed after surgery. It is a drug that is already approved by the FDA (Food & Drug Administration) for use as a sedative in hospitals and is currently used in the investigators Intensive Care Unit for this purpose. The investigators want to investigate if it also has pain relieving properties.
详细描述
The study involves the use of dexmedetomidine infusion intraoperatively during thoracic surgical procedures (not using an epidural) with discontinuation in the immediate postoperative period. A key feature in this study is to employ the drug infusion intraoperatively only.
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, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ( ≥ 21 years old) scheduled for Thoracic Surgery
排除标准
- •2nd or 3rd degree heart block as assessed by preoperative EKG
- •Use of dexmedetomidine within 28 days prior to day of surgery
- •Use of long acting opioids pre-operatively 28 days prior to day of surgery
- •Current or past diagnosis of a Major Psychiatric disorder precluding adequate outcome responses such as Schizophrenia, dementia, delirium etc. as recorded in the Pre-Operative Record.
- •Documentation of congestive heart failure and Ejection fraction < 30% if recorded in the Pre-Operative Record.
- •Planned use of an epidural for surgery or post-operative pain relief
- •Contraindication to use of NSAID, Acetaminophen or IV opioids.
- •Any known hypersensitivity to dexmedetomidine
- •Pregnant or breastfeeding
- •Abnormal liver function tests as related to the MSK guidelines for use of IV Acetaminophen
- •Yes or NO?; Is ALT greater than 2 x Upper Limit of Normal (> 75 U/L)?
- •Abnormal renal function tests as related to contraindications to use of IV Ketorolac
- •Yes or No?; Is Serum Creatinine < 1.5 mg/dl?
研究组 & 干预措施
Dexmedetomidine
continuous infusion of 0.4 mcg/kg/hr
干预措施: Dexmedetomidine (Drug)
Placebo
continuous infusion of 0.4 mcg/kg/hr
干预措施: Placebo (Drug)
结局指标
主要结局
Total Opioid Administered
时间窗: up to 4 hours
total opioid equivalents used postoperatively as measured by the total opioid administered in approximately the first 4 hours
次要结局
- Improves Analgesia(up to 24 hours)
- Number of Participants With Episodes of Nausea or Antiemetic Doses and/or Sedation(up to 24 hours)