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临床试验/NCT01374633
NCT01374633终止2 期

Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2011年12月最近更新:
适应症
相关药物

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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