Sensitivity of Electrocardiogram on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine: a Study in Children of Different Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- T-wave elevation in the ECG after intravenous administration of the test solution
研究概览
简要总结
The purpose of this prospective randomised study is to investigate electrocardiographic alterations after intravascular injection of three different test solutions of bupivacaine and epinephrine in anaesthetised children up to 16 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 0 to 16
- •parental consent
排除标准
- •allergy against local anaesthetics
研究组 & 干预措施
bupivacaine
test solution consists of bupivacaine 0.125%
干预措施: intravenous injection of test solution (Drug)
bupivacaine+epinephrine
test solution consists of bupivacaine 0.125% with epinephrine 1:200000
干预措施: intravenous injection of test solution (Drug)
epinephrine
test solution consists of epinephrine 1:200000
干预措施: intravenous injection of test solution (Drug)
结局指标
主要结局
T-wave elevation in the ECG after intravenous administration of the test solution
时间窗: 2 minutes
0.2 ml/kg test solution (bupivacaine or bupivacaine+epinephrine or epinephrine) is intravenously injected. The ECG is recorded over 2 minutes, printed and analysed later on regarding alterations of T-wave.
次要结局
- Alteration in heart rate caused by intravenous injection of the test solution(2 minutes)