Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients (SEPIA)
|ClinicalTrials.gov Identifier: NCT01374633|
Recruitment Status : Terminated (Sponsor decision)
First Posted : June 16, 2011
Last Update Posted : March 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Brain Injury||Drug: 1: Sevoflurane||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|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."
- ICP evolution [ Time Frame: 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".
- Sedation level [ Time Frame: during the 12 hours of sedation with sevoflurane ]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 ]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 ]increase of eardrum temperature more than 39°C is considered as potential malignant hyperthermia
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374633
|Reanimation Chirurgicale - Hôpital Kremlin Bicêtre|
|Kremlin Bicêtre, France, 94275|
|Principal Investigator:||Jacques DURANTEAU, MD,PhD||Assistance Publique - Hôpitaux de Paris|