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Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients (PROMIS)

This study has been terminated.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00336882
First received: June 13, 2006
Last updated: March 1, 2012
Last verified: March 2012

June 13, 2006
March 1, 2012
June 2006
October 2009   (final data collection date for primary outcome measure)
Lactate/pyruvate ratio concentration measured in the brain by microdialysis during the first 72 h of treatment [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Lactate/pyruvate ratio concentration measured in the brain by microdialysis during the first 72 h of treatment
Complete list of historical versions of study NCT00336882 on ClinicalTrials.gov Archive Site
  • Glutamate, glucose and glycerol concentration measured in the brain by microdialysis during the first 72 h of treatment. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
  • Glasgow outcome scale and Mc Nair score at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Glutamate, glucose and glycerol concentration measured in the brain by microdialysis during the first 72 h of treatment.
  • Glasgow outcome scale and Mc Nair score at 6 months.
Not Provided
Not Provided
 
Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients
Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients

Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury.

Severe traumatic brain injury is associated with an increased production of free radicals causing brain damage. First line treatment of these patients aims to maintain cerebral perfusion and includes deep anaesthesia. Propofol has recently shown anti oxidant properties that need to be confirmed when used in these patients. The main objective of this study is to evaluate the effect of propofol compared to midazolam on intra cerebral oxidative stress following severe traumatic brain injury. Measurements will be performed by use of intracerebral microdialysis.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Traumatic Brain Injury
  • Drug: Propofol
    Propofol at a dose of 1 mg/kg/hour with a dose increase of 1 mg/kg until therapeutic effect (with a maximum dose of 5 mg/kg/hour)
    Other Name: DIPRIVAN
  • Drug: Midazolam
    Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
    Other Name: HYPNOVEL
  • Active Comparator: 1
    Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
    Intervention: Drug: Midazolam
  • Experimental: 2
    Propofol at a dose of 1 mg/kg/hour with a dose increase of 1 mg/kg until therapeutic effect (with a maximum dose of 5 mg/kg/hour)
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
30
February 2010
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

Age≥18 years, Severe traumatic brain injury with a Glasgow coma scale ≤8 related to the trauma, Stage II, III or IV of the US Trauma Data Bank on the CT scan, Need for intracranial pressure monitoring, Written informed consent from the patient's next-of-kin. If no relative is present as the time of inclusion, the patients will be included according to the emergency procedure.

Non-inclusion Criteria:

Traumatic brain injury requiring urgent neurosurgical intervention due to blood collection, Contraindication to propofol or midazolam, History of head trauma > 12 hours before intra cranial pressure monitoring, Patient receiving propofol by continuous infusion since head trauma.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00336882
EUDRACT 2005-006213-40, PHRC/05-02, CIC0203/053
No
Rennes University Hospital
Rennes University Hospital
Ministry of Health, France
Principal Investigator: Yannick Mallédant, MD, PhD Rennes University Hospital
Study Chair: Bruno Laviolle, MD Rennes University Hospital
Rennes University Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP