Target-controlled Infusion (TCI) of Propofol for Induction in Children 3 to 11 Years
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- dose of propofol
研究概览
简要总结
The purpose of this study is to determine a effect-site concentration of propofol in children 3 to 11 years effective to make a induction of general 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
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obtained informed consent
- •children between 3 and 11 years
- •elective surgery under general anesthesia
- •no premedication
排除标准
- •body mass index for age > 95th percentile
- •chronic or acute intake of any sedative drug
- •any known adverse effect to the study drugs
研究组 & 干预措施
Grupo 1
Doses of induction: propofol 4 mcg/ml and fentanyl 3 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 2
Dose of induction: propofol 4.5 mcg/ml and fentanyl 3 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 3
Doses of propofol: propofol 5 mcg/ml and fentanyl 3 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 4
Doses of induction: propofol 5.5 mcg/ml and fentanyl 3 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 5
Doses of induction: propofol 6 mcg/ml and fentanyl 3 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 6
Doses of induction: propofol 4 mcg/ml and fentanyl 5 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 7
Doses of induction: propofol 4.5 mcg/ml and fentanyl 5 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 8
Doses of induction: propofol 5 mcg/ml and fentanyl 5 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 9
Doses of induction: propofol 5.5 mcg/ml and fentanyl 5 mcg/kg
干预措施: endotracheal intubation (Procedure)
Grupo 10
Doses of induction: propofol 6 mcg/ml and fentanyl 5 mcg/kg
干预措施: endotracheal intubation (Procedure)
结局指标
主要结局
dose of propofol
时间窗: two days (duration of hospitalization)
to obtain a dose appropriate of propofol in induction of anesthesia
次要结局
未报告次要终点
研究者
Ricardo Fuentes Henriquez
Profesor Asistente, Departamento de Anestesiología
Pontificia Universidad Catolica de Chile