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Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients (SEPIA)

Primary Purpose

Brain Injury

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
1: Sevoflurane
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring Sevoflurane, Brain injury, Intra cranial pressure, Sedation, Brain injury with initial Glasgow score less than 9

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Reanimation Chirurgicale - Hôpital Kremlin Bicêtre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1:patient with severe traumatic brain

Arm Description

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.
Haemodynamic tolerance
invasive mean arterial pressure (MAP) will be continuously recorded. Hypotension is defined by a MAP less than 60 mmHg.
Malignant hyperthermia screening
increase of eardrum temperature more than 39°C is considered as potential malignant hyperthermia

Full Information

First Posted
June 8, 2011
Last Updated
March 26, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01374633
Brief Title
Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
Acronym
SEPIA
Official Title
Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
Sevoflurane, Brain injury, Intra cranial pressure, Sedation, Brain injury with initial Glasgow score less than 9

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1:patient with severe traumatic brain
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
1: Sevoflurane
Other Intervention Name(s)
SEVORANE (Abbott), SEVOFLURANE (Baxter)
Intervention Description
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."
Primary Outcome Measure Information:
Title
ICP evolution
Description
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
Secondary Outcome Measure Information:
Title
Sedation level
Description
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
Title
Haemodynamic tolerance
Description
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
Title
Malignant hyperthermia screening
Description
increase of eardrum temperature more than 39°C is considered as potential malignant hyperthermia
Time Frame
during the 12 hours of sedation with sevoflurane

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques DURANTEAU, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reanimation Chirurgicale - Hôpital Kremlin Bicêtre
City
Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France

12. IPD Sharing Statement

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Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

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