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

Phase 3

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Midazolam; Drug: Propofol

• Registration Number: NCT00336882
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-13
• Study First Submitted QC: 2006-06-13
• Study First Posted: 2006-06-14
• Primary Completion: 2009-10
• Study Completion: 2010-02
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Midazolam	Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
2	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)

Primary Outcome Measures

Name	Time	Method
Lactate/pyruvate ratio concentration measured in the brain by microdialysis during the first 72 h of treatment	72 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Réanimation Chirurgicale - Hôpital de Pontchaillou; 🇫🇷 Rennes, France