Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Overview

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.

Full Title of Study: “Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

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.

Interventions

  • 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.”

Arms, Groups and Cohorts

  • Experimental: 1:patient with severe traumatic brain

Clinical Trial Outcome Measures

Primary Measures

  • 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”.

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jacques DURANTEAU, MD,PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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