Clinical trial NCT01374633: Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
Official title: Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Brain Injury
Keywords: Sevoflurane
Brain injury
Intra cranial pressure
Sedation
Brain injury with initial Glasgow score less than 9
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2011-06-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: ICP evolution
timeFrame: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane
Secondary outcomes:
measure: Sedation level
timeFrame: during the 12 hours of sedation with sevoflurane
measure: Haemodynamic tolerance
timeFrame: during the 12 hours of sedation with sevoflurane
measure: Malignant hyperthermia screening
timeFrame: during the 12 hours of sedation with sevoflurane
Other outcomes:
Locations:
city: Kremlin Bicêtre
country: France
facility: Reanimation Chirurgicale - Hôpital Kremlin Bicêtre
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jacques DURANTEAU, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: