Protection by Remote Ischemic Preconditioning During Congenital Cardiac Defects Repair Surgery With Sevoflurane But Not Propofol -A Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Troponin I levels
研究概览
简要总结
Remote ischemic preconditioning (RIPC) of the myocardium by limb ischemia/reperfusion may mitigate cardiac damage, but its interaction with the anesthetic regimen is unknown.
详细描述
The investigators will test if RIPC will be associated with differential effects depending on background anesthesia. Specifically, the investigators hypothesized that RIPC during sevoflurane anesthesia attenuates myocardial injury in patients undergoing congenital cardiac defects repair surgery and that effects may be different during propofol anesthesia.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric scheduled for cardiac surgery requiring the cardioplegic arrest and cardiopulmonary bypass
排除标准
- •Previous cardiac surgery
- •Urgent or emergent cases
- •Patient with the following diseases diabetes mellitus ,hypertension ,renal failure, hepatic and pulmonary diseases
研究组 & 干预措施
Group A
Sevoflurane plus remote ischemic preconditioning anesthesia will be induced and maintain with sevoflurane in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles
干预措施: Sevoflurane plus remote ischemic preconditioning (Drug)
Group B
anesthesia will be induced and maintain with total intravenous anesthesia (propofol, midazolam plus fentanyl) during plus remote ischemic preconditioning in addition to remote ischemic preconditioning which will be done after induction and before cardiopulmonary bypass by inflating the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3 cycles
干预措施: Total intravenous anesthesia plus remote ischemic preconditioning (Drug)
结局指标
主要结局
Troponin I levels
时间窗: within first 24 hours after cardiac surgery
The investigators will obtain blood samples for troponin I level pre-Cardiopulmonary bypass, 6, 12 and 24 hours after the surgery. Troponin I levels, as a marker of myocardial ischemia, have been used in previous adult and pediatric studies on preconditioning.
次要结局
- Mortality at 30 days(30 days)
- Highest inotropic score during the first 24 hours after cardiac surgery(within first 24 hours after cardiac surgery)
- Cardiac function(within first 24 hours of cardiac surgery)
研究者
Sayed Kaoud Abd-Elshafy
Associate profossor of anesthesia
Assiut University