Propofol in Expiratory Air, a Comparison With Plasma Propofol, BIS Value and Calculated Plasma Concentration During General Anesthesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Propofol plasma concentration versus simultaneous exhaled concentration
研究概览
简要总结
Children due for elective eye surgery in propofol based anesthesia will be kept at steady state propofol infusion for maintenance, ventilation via endotracheal tube. Exhaled propofol will be measured continously by Edmon (R) (BBraun) monitor and compared with arterial plasma samples of propofol, drawn 3-5 times during the procedure.
详细描述
The primary objective of the study is to determine the correlation between simultaneous concentrations of propofol in plasma and expiratory air in children during general anesthesia.
Key secondary objectives include correlating plasma and exhaled measurements of propofol with electroencephalogram (BIS) values and computer estimated propofol concentrations in plasma and brain (TCI: target control infusion) Primary endpoint: Exhaled air and plasma concentration ratios of propofol during general anesthesia in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective eye surgey
排除标准
- •known propofol hypersensitivity
研究组 & 干预措施
propofol
propofol general anesthesia, exhaled measurement of propofol
干预措施: Edmon (Device)
结局指标
主要结局
Propofol plasma concentration versus simultaneous exhaled concentration
时间窗: 5 hours
repeated blood samples of propofol concentration
Realtionship between Paedfusor-estimated propofol concentration and measured concentration in plasma samples
时间窗: During general anaesthesia
次要结局
- Propofol exhaled correlation versus Bispectral Index value (BIS)(5 hours)
研究者
Johan C Ræder
Professor, Consultant
Oslo University Hospital