Effect of Strategy for Blood Pressure Control on Cerebral Oxygen Balance During Aortic Coarctation Repair: a Randomized Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cerebral saturation
研究概览
简要总结
In a prospective and randomized study protocol, three different blood pressure regulating agents (nitroprusside, nitroglycerine, sevoflurane) will be compared concerning their effect on the cerebral oxygen balance between both hemispheres during aortic coarctation repair. Cerebral and somatic saturation will be monitored non-invasively and continuously via optical sensors applied to the right and left forehead and the somatic regions. Arterial blood pressure, central venous pressure, heart rate and systemic saturation will be recorded continuously. Intermittently, arterial and venous blood gas analysis will be performed at 6 definite time intervals. The study ends at the end of the operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All neonates and infants
- •Aged 0-18 year
- •With aortic coarctation requiring surgical correction without the additional use of cardiopulmonary bypass will be included.
排除标准
- •All patients with an associated cardiac effect are excluded.
研究组 & 干预措施
1
Administration of nitroprusside
干预措施: nitroprusside (Drug)
2
Administration of nitroglycerine
干预措施: nitroglycerine (Drug)
3
Administration of sevoflurane
干预措施: sevoflurane (Drug)
结局指标
主要结局
Cerebral saturation
时间窗: During operation
次要结局
未报告次要终点