Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Brain Injury

Intervention / Treatment
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* Drug: 1: Sevoflurane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: severe traumatic brain injury (glasgow < 8) age > 18 no surgery scheduled sedation with midazolam and sufentanil ICP sensor Exclusion Criteria: external ventricular derivation pregnancy antecedent of malign hyperthermia haemodynamic instability

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1:patient with severe traumatic brain<br> | Drug: 1: Sevoflurane<br>* Mean sevoflurane infusion rate will be around 6 ml/h or 72 ml for 12 hours. Maximal infusion rate will be around 12 ml/h, or 144 ml for 12 hours. Packaging: bottle containing 250 ml of liquid sevoflurane for evaporation. Administration mode: anaesthetic conserving device for volatile anaesthetics.<br>* Other names: SEVOFLURANE (Baxter);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICP evolution | 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. | ICP will be continuously recorded during the 12 hours of sedation with sevoflurane | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sedation level | sedation level will be evaluated with the measure of the Bispectral Index and the SAS sedation score. Proportion of time with BIS of 45-65% and SAS <2, which are the objective of sedation level, will be recorded. | during the 12 hours of sedation with sevoflurane | 
| Haemodynamic tolerance | invasive mean arterial pressure (MAP) will be continuously recorded. Hypotension is defined by a MAP less than 60 mmHg. | during the 12 hours of sedation with sevoflurane | 
| Malignant hyperthermia screening | increase of eardrum temperature more than 39°C is considered as potential malignant hyperthermia | during the 12 hours of sedation with sevoflurane | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sevoflurane, Brain injury, Intra cranial pressure, Sedation, Brain injury with initial Glasgow score less than 9