A Phase 2 interventional study of 1: Sevoflurane in Brain Injury, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
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.
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.
2,125 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
This study's enrollment of 10 is below the median of 48 across 1,341 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
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Exclusion Criteria:
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."
Also known as: SEVORANE (Abbott), SEVOFLURANE (Baxter)
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".
Time frame: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane
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.
Time frame: 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.
Time frame: 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
Time frame: during the 12 hours of sedation with sevoflurane
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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