Hemodynamic Effects of Dopamine Versus Norepinephrine Under General Anesthesia in Infant With Congenital Heart Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changes of cardiac index
研究概览
简要总结
Participants under general anesthesia will be randomly treated with an adjusted dose dopamine or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is recorded by PRAM and the change of cardiac index is compared between groups.
详细描述
After intubation under general anesthesia, radial arterial is cannulated and pressure transducer is connected to MostCare(core technique PRAM). CI, SVRI, SVI, SVV, dp/dt and HR are recorded before and after a infusion of dopamine or norepinephrine to elevate 10% of mean arterial pressure. Changes of these hemodynamic data are compared.
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
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undertake cardiac surgery for congenital heart disease
排除标准
- •Aortic valve or aortic disease
- •severe arrhythmia
- •use of cardiovascular active drugs before anesthesia
- •need to use a combination of different cardiovascular support drugs after anesthesia
研究组 & 干预措施
norepinephrine
infusion of norepinephrine with a adjusted dose to elevate 10% of mean arterial pressure
干预措施: norepinephrine (Drug)
Dopamine
infusion of dopamine with a adjusted dose to elevate 10% of mean arterial pressure
干预措施: dopamine (Drug)
结局指标
主要结局
changes of cardiac index
时间窗: 20 minutes
the differences of cardiac index between after and before the intervention (l/min/m2)
次要结局
- changes of the maximal slope of systolic upstroke(20 minutes)
- changes of heart rate(20 minutes)
- changes of systemic vascular resistance index(20 minutes)
- changes of stroke volume index(20 minutes)
研究者
Zhijian Zhou
vice director of department of anesthesiology
Children's Hospital of Fudan University