Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients (SEPIA)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients|
- ICP evolution [ Time Frame: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane ] [ Designated as safety issue: Yes ]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".
- Sedation level [ Time Frame: during the 12 hours of sedation with sevoflurane ] [ Designated as safety issue: Yes ]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.
- Haemodynamic tolerance [ Time Frame: during the 12 hours of sedation with sevoflurane ] [ Designated as safety issue: Yes ]invasive mean arterial pressure (MAP) will be continuously recorded. Hypotension is defined by a MAP less than 60 mmHg.
- Malignant hyperthermia screening [ Time Frame: during the 12 hours of sedation with sevoflurane ] [ Designated as safety issue: Yes ]increase of eardrum temperature more than 39°C is considered as potential malignant hyperthermia
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Experimental: 1:patient with severe traumatic brain||
Drug: 1: Sevoflurane
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."
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01374633
|Contact: Jacques DURANTEAU, MD,PhD||+33 (0)1 45 21 34 firstname.lastname@example.org|
|Contact: Malcie MESNIL, MD||+33(0) 1 45 21 34 email@example.com|
|Reanimation Chirurgicale - Hôpital Kremlin Bicêtre||Recruiting|
|Kremlin Bicêtre, France, 94275|
|Principal Investigator: Jacques DURANTEAU, MD, PhD|
|Principal Investigator:||Jacques DURANTEAU, MD,PhD||Assistance Publique - Hôpitaux de Paris|