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

This study has been terminated.
(Sponsor decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374633
First Posted: June 16, 2011
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention Phase
Brain Injury Drug: 1: Sevoflurane Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome 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 Outcome 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


Enrollment: 10
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1:patient with severe traumatic brain 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."
Other Names:
  • SEVORANE (Abbott)
  • SEVOFLURANE (Baxter)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374633


Locations
France
Reanimation Chirurgicale - Hôpital Kremlin Bicêtre
Kremlin Bicêtre, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Jacques DURANTEAU, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01374633     History of Changes
Other Study ID Numbers: P100206
2011-000253-23 ( Other Identifier: Eudra CT )
First Submitted: June 8, 2011
First Posted: June 16, 2011
Last Update Posted: March 27, 2015
Last Verified: March 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sevoflurane
Brain injury
Intra cranial pressure
Sedation
Brain injury with initial Glasgow score less than 9

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs