Dexmedetomidine Based Versus Propofol Based Anesthesia in Patients Undergoing Coronary Revascularization: a Randomized, Double-blind Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- cardiac index
研究概览
简要总结
Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the depth of sedation and provides analgesia, cardio protection, renal protection, and neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor agonist that modulates the release of catecholamines from the central and autonomic nervous systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are calm and cooperative (1). No other sedative agent has this feature, and sedated patients frequently awaken in a confused state. Investigators are conducting this study project to compare between dexmedetomidine based and propofol based anesthetic techniques with regard to hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB for coronary revascularization.
详细描述
100 patients undergoing elective CPB for coronary revascularization surgery. On the morning of operation the patients were randomized to receive one of two anesthetic techniques dependent on the type of sedation used. Standard anesthetic technique will be used for all patients except for using dexmedetomidine sedation in one group and propofol sedation in the other group.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass
排除标准
- •Severely impaired left ventricular function (ejection fraction <40%)
- •Valvular heart disease
- •Low cardiac output syndrome
- •Uncontrolled rapid atrial fibrillation
- •On plavix less than one week
- •Severe systemic non-cardiac disease
- •Infectious disease
- •Poorly controlled diabetes mellitus
- •patients on corticosteroids or other immunosuppressive treatment
研究组 & 干预措施
Dexmedetomidine group
干预措施: Dexmedetomidine (Drug)
Propofol group
干预措施: propofol (Drug)
结局指标
主要结局
cardiac index
时间窗: within intraoperative period
cardiac index measured in L/min/m2
次要结局
- heart rate(within intraoperative period)
- pulmonary capillary wedge pressure(within intraoperative period)
- mean pulmonary artery pressure(within intraoperative period)
- cardiac output(within intraoperative period)
- inotrope score(1st 24 hours)
- duration of mechanical ventilation(1st week)
- sedation score(1st 24 hours)
- mean arterial blood pressure(within intraoperative period)
- central venous pressure(within intraoperative period)
- systemic vascular resistance index(within intraoperative period)
- pulmonary vascular resistance index(within intraoperative period)
- stroke volume index(within intraoperative period)
- left ventricular stroke work index(within intraoperative period)
研究者
Sayed Kaoud Abd-Elshafy
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University
Assiut University