The Hemodynamic Effects of Propofol Versus Sevoflurane for Induction of Anesthesia in Healthy Infants as Measured by Electrical Cardiometry: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- cardiac index
研究概览
简要总结
This comparative study aims to investigate the haemodynamic safety profile for induction of general anesthesia in infants 3 months or less guided by electrical cardiometry parameters versus sevoflurane.
详细描述
This study aims to investigate the hemodynamic effects of both propofol and sevoflurane for induction of anesthesia in infants less than 3 months of age by electrical cardiometry. The investigators hypothesized that propofol will have a safe hemodynamic profile for induction of anesthesia in infants less than 3 months of age as measured by electrical cardiometry in addition to its favorable pharmacokinetic profile of rapid induction and optimal intubation conditions.It is conducted at Abu Al Reesh Children's Hospital, Faculty of Medicine, Cairo University based on an institutional protocol used as a standard of care to induce anesthesia
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants aged 3 months or less scheduled for elective surgery
排除标准
- •significant structural congenital heart disease
- •intracranial malformation.
- •preexisting hemodynamic instability.
- •history of seizures, opioids, and/or hypnotic administration.
- •prematurity (defined as gestational age <37 weeks)
研究组 & 干预措施
Sevoflurane
Sevoflurane (4%) will be used for inhalational induction.
干预措施: Propofol (Drug)
propofol
Propofol at a dose of 2mg/kg will be administered I.V. .
干预措施: Propofol (Drug)
结局指标
主要结局
cardiac index
时间窗: 15 minutes
L/min/m2
次要结局
- MAP(15 minutes)
研究者
Shymaa Fathy
Lecturer of anesthesia and SICU
Cairo University