Pilot Study: The Effect of Intraoperative Ketamine on Analgesia Post-Cardiac Surgery and Prevention of Chronic Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Quantity of Opioids Used in the First 48 Hours Postoperatively
研究概览
简要总结
Randomized, controlled, double-blind pilot study evaluating the effect of an intraoperative infusion of intravenous Ketamine on the quantity of opioid consumed postoperatively in coronary artery bypass surgery patients receiving a median sternotomy.
详细描述
This is a randomized, controlled, double-blind pilot study to determine the effectiveness of intraoperative Ketamine administration on pain after coronary artery bypass surgery. Patients will be randomized to receive ketamine or saline prior to incision, with a continuous infusion throughout surgery. Opioid dose administered in the first 48 hours will then be documented as the primary outcome
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older coming for coronary artery bypass surgery with a left ventricular ejection fraction over 50% and able to consent prior to surgery
排除标准
- •Minimally invasive cardiac surgery
- •Preoperative opioid use
- •Preoperative hepatic or renal dysfunction
研究组 & 干预措施
Intervention
Intraoperative infusion of ketamine
干预措施: Ketamine Hydrochloride (Drug)
Control
Control group receiving a saline infusion
干预措施: Normal Saline Flush, 0.9% Injectable Solution_#1 (Drug)
结局指标
主要结局
Quantity of Opioids Used in the First 48 Hours Postoperatively
时间窗: First 48 hours after arrival to the ICU
Opioids used, in Dilaudid equivalents
次要结局
- Postoperative Nausea and Vomiting(48 hours after ICU arrival)
- Intensive Care Unit Length of Stay(1 day - 2 weeks)
- Time to Mobilization(During hospital stay)
- Pain Scores (Visual Analog Scale)(Postoperative days 2)
- Quantity of Opioids Used(24 hours postoperatively)
- Hospital Length of Stay(5 days - 2 weeks)
- Time to Extubation(4 hours - 2 weeks)
- Delirium(ICU stay)
- Time to Ambulation(1 week postoperatively)
研究者
Matthew Cameron
Assistant Professor
Jewish General Hospital