Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury, propofol, oxidative stress, microdialysis
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 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.
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 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.
Interventions
DRUGPropofol
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)
DRUGMidazolam
Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
Sponsors
Ministry of Health, France
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lactate/pyruvate ratio concentration measured in the brain by microdialysis during the first 72 h of treatment | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Glutamate, glucose and glycerol concentration measured in the brain by microdialysis during the first 72 h of treatment. | 72 hours |
| Glasgow outcome scale and Mc Nair score at 12 months. | 12 months |
Countries
France
Outcome results
None listed