Effect of Propofol vs Dexmedetomidine or Propofol+Dexmedetomidine on Reducing the Frequency of Arrhythmia in Patients After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- incidence of arrhythmia
研究概览
简要总结
Arrhythmias early in the recovery period after cardio thoracic surgery are common they develop in 11 to 40 percent of patients after coronary-artery bypass grafting. The right chose of sedative agent could decrease the level of arrhythmia incidence.
详细描述
Arrhythmias are really common in patients after cardiac surgery. Most of the patients get sedation after cardiac surgery. The goal is to determine if the propofol (PR) (sedative agent), dexmedetomidine (DEX)(selective α2-adrenergic receptor (α2-AR) agonist) or their combination could improve and decrease the incidence of the arrhythmia in patients 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
- Prevention
- 盲法
- None
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
- •Multi vascular lesions of the coronary arteries according to coronary angiography;
- •Heart valve damage was confirmed by heart ultrasound, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
- •Age of patients from 18-80 years;
排除标准
- •Refusal to participate;
- •Hypersensitivity to propofol, dexmedetomidine;
- •Acute renal failure that occurred during surgery (ClCr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy)
研究组 & 干预措施
Propofol Group
Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol using a syringe pump at the dose of 1-1.5 mg / kg / h
干预措施: Propofol (Drug)
Dexmedetomidine
Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of Dexmedetomidine using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine and propofol
Patient sedation after cardiac surgery at the intensive care unit.
Sedation group DEX+PR:
continuous infusion of propofol using a syringe pump at the dose of 0.5-1.5 mg / kg / h and dexmedetomidine 0.2-0.7 mcg\kg\h
干预措施: Dexmedetomidine and propofol (Drug)
结局指标
主要结局
incidence of arrhythmia
时间窗: day of the discharge from the hospital (assessed up to day 5)
incidence of deviation from the rhythm before the surgery and at the day of the discharge from the hospital after cardia surgery
次要结局
未报告次要终点
研究者
Plechysta Yelyzaveta
Chief of the anesthesia Department
Anesthesia Research Group UA