Status:
TERMINATED
Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00336882
Start Date
June 1 2006
End Date
February 1 2010
Last Update
March 2 2012
Active Locations (1)
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1
Réanimation Chirurgicale - Hôpital de Pontchaillou
Rennes, France, 35033