Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Phase 2

Terminated

• Conditions: Brain Injury

• Registration Number: NCT01374633
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2011-06-08
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Study Start: 2011-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ICP evolution	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".

Secondary Outcome Measures

Name	Time	Method
Sedation level	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	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	during the 12 hours of sedation with sevoflurane	increase of eardrum temperature more than 39°C is considered as potential malignant hyperthermia

Trial Locations

Locations (1)

Reanimation Chirurgicale - Hôpital Kremlin Bicêtre; 🇫🇷 Kremlin Bicêtre, France