Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- ICP evolution
研究概览
简要总结
Main purpose of the study is to evaluate the effect of sevoflurane on intra cranial pressure (ICP) after traumatic brain injury. Patients admitted for traumatic brain injury equipped with ICP measurement will be sedated with sevoflurane via the Anaconda device during 12 hours. Sedation will be controlled with BIS.
详细描述
Sedation is most of the time required for ICP management after traumatic brain injury. Sevoflurane, an inhaled anaesthetic drug is commonly used in operatory room. Thanks to a new device, the Anaconda, it now can be applied to intensive care patients. His advantages a rapid elimination after administration stops, which can allow an early neurologic evaluation, very important for traumatic brain injury patients.We will study the effect of sevoflurane administration on ICP of TBI patients. Patients admitted for severe TBI (Glasgow come scale < 8), equipped with ICP sensor, elder than 18 years old will be include. A sedation with sevoflurane will be administrated during 12 hours instead of classical intra venous sedation with midazolam, depending on BIS score. ICP evolution will be characterised in success if < 30 mmHg or failure if ≥ 30 mmHg.6 patients will be included for the first phase. The study will be stopped if the failures are ≥ 2. Otherwise, 27 patients will be included. Study will be stopped if failures number ≥ 5 before the end if the inclusion period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe traumatic brain injury (glasgow < 8)
- •age > 18
- •no surgery scheduled
- •sedation with midazolam and sufentanil
- •ICP sensor
排除标准
- •external ventricular derivation
- •pregnancy
- •antecedent of malign hyperthermia
- •haemodynamic instability
结局指标
主要结局
ICP evolution
时间窗: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane
patients where ICP increase more than 30 mmHg during more than 15 minutes will be characterized as "failure". Patients whose ICP do not increase during the 12 hours of sedation with sevoflurane will be characterized as "success".
次要结局
- Sedation level(during the 12 hours of sedation with sevoflurane)
- Haemodynamic tolerance(during the 12 hours of sedation with sevoflurane)
- Malignant hyperthermia screening(during the 12 hours of sedation with sevoflurane)
