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

Sponsors and Collaborators:	Rennes University Hospital Ministry of Health, France
Information provided by:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT00336882

Purpose

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.

Condition	Intervention	Phase
Severe Traumatic Brain Injury	Drug: Propofol Drug: Midazolam	Phase III

MedlinePlus related topics: Anesthesia Injuries Traumatic Brain Injury Wounds

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients

Further study details as provided by Rennes University Hospital:

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 ]

Estimated Enrollment:	30
Study Start Date:	June 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.	Drug: Midazolam Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
2: Experimental 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)	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)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00336882

Contacts

Contact: Yannick Mallédant, MD, PhD	33-2-9928-4246	yannick.malledant@chu-rennes.fr
Contact: Bruno Laviolle, MD	33-2-9928-3715	bruno.laviolle@chu-rennes.fr

Locations

France
Réanimation Chirurgicale - Hôpital de Pontchaillou	Recruiting
Rennes, France, 35033
Contact: Yannick Mallédant, MD, PhD 33-2-9928-4246 yannick.malledant@chu-rennes.fr
Sub-Investigator: Michèle Tanguy, MD
Sub-Investigator: Jean-Paul Bleichner, MD
Sub-Investigator: Xavier Morandi, MD, PhD
Principal Investigator: Yannick Malledant, MD, PhD
Sub-Investigator: Bruno Laviolle, MD

Sponsors and Collaborators

Rennes University Hospital

Ministry of Health, France

Investigators

Principal Investigator:	Yannick Mallédant, MD, PhD	Rennes University Hospital
Study Chair:	Bruno Laviolle, MD	Rennes University Hospital

More Information

Responsible Party:	Rennes University Hospital ( Direction of Clinical Research and Strategy )
Study ID Numbers:	EUDRACT 2005-006213-40, PHRC/05-02, CIC0203/053
Study First Received:	June 13, 2006
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00336882
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:

traumatic brain injury
propofol
oxidative stress
microdialysis

Study placed in the following topic categories:

Craniocerebral Trauma
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Stress

Trauma, Nervous System
Propofol
Midazolam
Brain Diseases
Brain Injuries

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics

Central Nervous System Depressants
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009