The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients (body weight < 10 kg)
- •diagnosed with congenital heart diseases
- •scheduled for repair operation with CPB
- •in the Department of Cardiovascular Surgery, Xijing Hospital
排除标准
- •systemic infections
- •other systemic diseases
研究组 & 干预措施
Sevoflurane
Patients will receive 2% sevoflurane via oxygenator during CPB
干预措施: Sevoflurane (Drug)
Control
Patients will receive only oxygen and air through oxygenator
干预措施: Control (Other)
结局指标
主要结局
all cause mortality
时间窗: within the first 30 days (plus or minus 3 days) after surgery
All cause mortality after the cardaic surgery, patients will be followed up for 30 days
次要结局
- serum cTnI concentrations(48 h after the surgery)