Back to resultsAnaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients (PROMIS)
Primary Purpose
Traumatic Brain Injury
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Propofol
Midazolam
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, propofol, oxidative stress, microdialysis
Eligibility 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 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.
Sites / Locations
- Réanimation Chirurgicale - Hôpital de Pontchaillou
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
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)
Outcomes
Primary Outcome Measures
Lactate/pyruvate ratio concentration measured in the brain by microdialysis during the first 72 h of treatment
Secondary Outcome Measures
Glutamate, glucose and glycerol concentration measured in the brain by microdialysis during the first 72 h of treatment.
Glasgow outcome scale and Mc Nair score at 12 months.
Full Information
NCT ID
NCT00336882
First Posted
June 13, 2006
Last Updated
March 1, 2012
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT00336882
Brief Title
Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients
Acronym
PROMIS
Official Title
Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Study Start Date
June 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
traumatic brain injury, propofol, oxidative stress, microdialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
Arm Title
2
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
DIPRIVAN
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
HYPNOVEL
Intervention Description
Midazolam at a dose of 0,03 mg/kg/hour with dose increasing of 0,02 mg/kg/hour until therapeutic effect.
Primary Outcome Measure Information:
Title
Lactate/pyruvate ratio concentration measured in the brain by microdialysis during the first 72 h of treatment
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Glutamate, glucose and glycerol concentration measured in the brain by microdialysis during the first 72 h of treatment.
Time Frame
72 hours
Title
Glasgow outcome scale and Mc Nair score at 12 months.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yannick Mallédant, MD, PhD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bruno Laviolle, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Réanimation Chirurgicale - Hôpital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Learn more about this trial
Anaesthesia With Propofol Versus Midazolam : Effect on Oxidative Stress in the Brain of Head Trauma Patients
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