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

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.

Official Title

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

Conditions

• Severe Traumatic Brain Injury

Study Type

Interventional

Study Design

Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

• 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 ]

Secondary Outcome Measures:

• 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 ]

Study Start

June 2006

Eligibility & Criteria

Official Title

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

Conditions

• Severe Traumatic Brain Injury

Study Type

Interventional

Study Design

Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

• 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 ]

Secondary Outcome Measures:

• 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 ]

Study Start

June 2006

Eligibility & Criteria

Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts 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. Exclusion 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.

Total Enrolment

30

Contact Details

Yannick Mallédant, (MD, PhD)
33-2-9928-4246
yannick.malledant@chu-rennes.fr

Bruno Laviolle, (MD)
33-2-9928-3715
bruno.laviolle@chu-rennes.fr

Location:

Réanimation Chirurgicale
Hôpital de Pontchaillou
Rennes, France, 35033