Time to Peak Effect of Propofol in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Time to peak effect of a propofol bolus
研究概览
简要总结
In order to determine the speed of onset of the anaesthetic propofol in children, investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome measure is the time to peak effect of a bolus of proposal, which is measured by analysing the electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will enable investigators to quantify the difference with age in the hypnotic effect of propofol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The analysis of the electroencephalogram will be blinded to the age of the participant.
入排标准
- 年龄范围
- 1 Year 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study population will be healthy children in the ranges of 1-6 and 8-13 years of age having surgery with American Society of Anaesthesia (ASA) grades I-II (ie. no prior functional limitation due to comorbidities) that fulfil the following points:
- •parental written consent obtained at least a day prior to begin of the subject's study episode; and
- •the child is appropriate for induction and maintenance of anaesthesia with propofol.
排除标准
- •Any significant subject co-morbidity (ASA III or IV);
- •Withdrawal of consent/assent at any point in the study;
- •Failure to cannulate a peripheral vein prior to induction after two attempts;
- •Any other reason making IV induction with propofol impossible;
- •Allergy to propofol (or its emulsion carrier), Eutectic Mixture of Local Anesthetics (EMLA) cream or Nitrous Oxide (N2O);
- •previous enrolment in the study;
- •Any anaesthetic problem that would take precedence over completion of the study protocol.
研究组 & 干预措施
Age 1-6 years
Induction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes.
The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups.
干预措施: Propofol (Drug)
Age 8-13 years
Induction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes.
The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups.
干预措施: Propofol (Drug)
结局指标
主要结局
Time to peak effect of a propofol bolus
时间窗: up to 20 minutes from baseline until peak effect following second bolus administration
This is the time from the start of the propofol bolus administration to the maximal suppression of the electroencephalogram; per subject two boli will be administered
次要结局
未报告次要终点