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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01374633
First received: June 8, 2011
Last updated: June 5, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    increase of eardrum temperature more than 39°C is considered as potential malignant hyperthermia


Estimated Enrollment: 27
Study Start Date: December 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374633

Contacts
Contact: Jacques DURANTEAU, MD,PhD +33 (0)1 45 21 34 41 jacques.duranteau@bct.aphp.fr
Contact: Malcie MESNIL, MD +33(0) 1 45 21 34 41 malcie.mesnil@bct.aphp.fr

Locations
France
Reanimation Chirurgicale - Hôpital Kremlin Bicêtre Recruiting
Kremlin Bicêtre, France, 94275
Principal Investigator: Jacques DURANTEAU, MD, PhD         
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

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01374633     History of Changes
Other Study ID Numbers: P100206, 2011-000253-23
Study First Received: June 8, 2011
Last Updated: June 5, 2014
Health Authority: France: Ministry of Health

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:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Sevoflurane
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 23, 2014