Cardioprotective Effect of Dexmedetomidine in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- cardiac troponin I
研究概览
简要总结
Dexmedetomidine, an alpha-2 agonist, is a sedative that is widely used in various clinical settings because, compared to benzodiazepines, it preserves respiratory function better and its duration of action is short.
Recent experimental studies showed a possibility that dexmedetomidine may have an organoprotective effect from ischemic-reperfusion injury by reducing inflammatory response. Besides, dexmedetomidine is known to be related with attenuated sympathetic tone and improved microcirculation.
Taken together, it is plausible that dexmedetomidine exerts cardioprotection in patients undergoing cardiac surgery with cardiopulmonary bypass and aortic cross-clamp.
The aim of this trial is to test the effect of dexmedetomidine on postoperative cardiac troponin I measurements in patients undergoing cardiac surgery.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cardiac surgery utilizing cardiopulmonary bypass and aortic cross-clamp
排除标准
- •Coronary artery bypass grafting
- •Concomitant cryo-Maze procedure
- •Heart transplantation
- •Concomitant major non-cardiac surgery
- •Isolated complicated congenital heart surgery
- •descending thoracic aorta surgery with partial cardiopulmonary bypass
- •Emergency surgery
- •Minimally invasive or robot-assisted surgery
- •Estimated GFR <30 ml/min/1.73 m2
- •Documented end-stage renal disease
- •Preoperative renal replacement therapy
- •Preoperative history of percutaneous coronary intervention within 6 month before surgery
- •Acute coronary syndrome within 4 weeks before surgery
- •Preoperative mechanical circulatory support devices
研究组 & 干预措施
Control
Placebo group using normal saline infusion
干预措施: Control (Drug)
Dexmedetomidine
From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
cardiac troponin I
时间窗: Three days after surgery
Area under the curve of cardiac troponin I measured at 0, 6, 24, 48, 72 hours after surgery
次要结局
未报告次要终点
研究者
Karam Nam, MD
Clinical Assistant Professor
Seoul National University Hospital