Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 798
- 试验地点
- 1
- 主要终点
- Number of Patients With Delirium
研究概览
简要总结
Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
详细描述
The investigator goal is to evaluate the effects of intraoperative and postoperative dexmedetomidine sedation (versus placebo after 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
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-85 years old;
- •Scheduled for cardiac surgery with bypass (CABG, valve, or combined);
- •Able to provide a written informed consent;
- •Hemodynamically stable (heart rate>= 55).
排除标准
- •Sick sinus syndrome or Wolff-Parkinson-White syndrome
- •Atrio-ventricular block
- •Hypersensitivity or known allergy to dexmedetomidine
- •Hepatic disease, e.g. twice the normal level of liver enzymes
- •Atrial fibrillation within 1 preoperative month;
- •Permanent pacemaker;
- •Use of amiodarone or dexmedetomidine within the last 30 days;
- •Patients with an ejection fraction under 30% or who had severe heart failure
- •Myocardial infarction in the previ¬ous 7 days;
- •Body mass index =< 40 (BMI= mass (kg) / height (m)2);
- •Those taking clonidine within last 48 hours.
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine infusion, without a bolus dose, (or a comparable volume of placebo) will be initiated before the surgical incision at a rate of 0.1 mcg/kg/hr at the end of bypass, the dose will be increased to 0.2 mcg/kg/hr. Postoperatively patients will continue to receive the study medication at a rate of 0.4mcg/kg/hr. The study medication infusion will be continued for a total of 24 hours from the initial administration time intra-operatively.
干预措施: Dexmedetomidine (Drug)
Placebo
normal saline administration matching dexmedetomidine rate of infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Patients With Delirium
时间窗: From the end of surgery to postoperative day 5
The occurrence of postoperative delirium
Number of Patients With Atrial Arrhythmia
时间窗: From the end of surgery to postoperative day 5
The occurrence of postoperative atrial arrhythmias
次要结局
- Number of Patients With Acute Kidney Injury(From the end of surgery to postoperative day 5)
- Number of Patients With Incisional Pain(90 days after surgery)
研究者
Alparslan Turan
Staff
The Cleveland Clinic