Comparing Effect of Propofol, Dexmedetomidine and Their Combination on Duration Mechanical Ventilation in Patient 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
- length of the mechanical ventilation
研究概览
简要总结
There is a direct relationship between the sedative agent and the duration of ventilation.
详细描述
Sedation and sedative agent have direct correlation to the mechanical length. As known mechanical length could increase length of the hospital stay (LOHS) and mortality rate. The right sedative agent can decrease the length go the mechanical ventilation. The goal of the research to compare 3 sedation strategies and their influence to the duration of mechanical ventilation.
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, 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; • Patient consent to participate in the study;
排除标准
- •Refusal to participate;
- •Hypersensitivity to propofol, dexmedetomidine;
- •Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium);
- •Occurred ischemic stroke;
- •History of the ischemic stroke;
- •History of the neurodegenerative diseases;
- •History of the mental disorders;
- •Use of neuroleptics, antidepressants for the last 5 years;
- •History of the cardiac surgery in the past;
- •Patients with chronic pulmonary disease (GOLD 3-4)
- •Patients with asthma (moderate or severe),
- •Participation in any other clinical trial;
- •Chronic renal failure (ClCr less than 50 ml / h)
- •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)
- •Chronic hepatic insufficiency if there are laboratory signs of hypo coagulation without the use of anticoagulant therapy (INR> 1.5)
- •If the patient has not stopped taking anticoagulants or antiplatelet agents in the preoperative period: warfarin 5 days before surgery, clopidogrel 5-7 days before surgery, xarelto / pradaxa 3 days before surgery),
- •History of the hematological disease;
- •Alcohol abuse in the anamnesis (3-4 times a week).
- •Condition after chemotherapy;
- •Pregnancy, lactation.
研究组 & 干预措施
propofol
Patient sedation after cardiac surgery at the intensive care unit. Continuous infusion of propofol (hypnotic agent) 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 (selective α2-adrenergic receptor (α2-AR) agonist) using a syringe pump at the dose of 0.5-1.0 mcg/ kg / h
干预措施: Dexmedetomidine (Drug)
propofol and dexmedetomidine
Patient sedation after cardiac surgery at the intensive care unit. 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: Propofol and dexmedetomidine (Drug)
结局指标
主要结局
length of the mechanical ventilation
时间窗: after cardiac surgery till extubation (up to first 24 hour after surgery)
measure the length of the mechanical ventilation
次要结局
- Length of the ICU stay(at the day of discharge of ICU (assessed up to day 5))
- Length of the hospital stay(at the day of discharge of hospital (assessed up to day 5))
研究者
Plechysta Yelyzaveta
Chief of the anesthesia department
Anesthesia Research Group UA