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

NCT00336882 | Terminated Phase 3

• 3 other identifiers: EUDRACT 2005-006213-40PHRC/05-02CIC0203/053
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; propofol; oxidative stress; microdialysis

Outcome Measures

Primary Outcomes (1)

• Lactate/pyruvate ratio concentration measured in the brain by microdialysis during the first 72 h of treatment

  72 hours

Secondary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Propofol DRUG

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)

Also known as: DIPRIVAN

2

Midazolam DRUG

Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.

Also known as: HYPNOVEL

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ministry of Health, France: collaborator

Study Sites (1)

Réanimation Chirurgicale - Hôpital de Pontchaillou

Rennes, 35033, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Propofol; Midazolam

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yannick Mallédant, MD, PhD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

• Bruno Laviolle, MD

  Rennes University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2006
• First Posted: June 14, 2006
• Study Start: June 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 2, 2012

Record last verified: 2012-03

Locations

FR (1)