Head Trauma Clinical Trial
Official title:
Effect of Ketamine Versus Sufentanil on Cerebral Glutamate After Traumatic Brain Injury : a Randomized, Double-blinded, Microdialysis Study
The objective of the study is to compare the effects of 48 hours ketamine infusion versus
sufentanil infusion on brain glutamate concentrations measured with microdialysis after
traumatic brain injury.
We hypothesize that ketamine infusion will decrease high glutamate values faster than
sufentanil.
Inclusion of 20 consecutive head trauma patients. Randomization and double-blind to compare
the effects of ketamine versus sufentanil on brain glutamate concentrations measured with
microdialysis.
Ketamine is an anti-N-methyl-D-aspartate (NMDA) medication. It is supposed to limit
excitotoxicity of amino-acids, especially glutamate. Glutamate is known to be elevated in
more than 60% of the severe head trauma patients. It induces cortical spreading depression
which can aggravate prognosis. It's a daily used medication in anesthesia and intensive care
units for sedation and induction of anesthesia. It's the recommended medication for
induction of unstable wounded soldiers on the field because of its neutrality on
haemodynamic state.
Sufentanil is the reference opioid for sedation in ICU in Europe. It can induce hypotension
which is deleterious for cerebral perfusion pressure after brain trauma.
In our unit, patients with severe head injury are monitored by a triple lumen access device
including ICP (IntraCerebral Pressure), PtiO2 (oxygen pressure in the brain) and
microdialysis. This last monitoring allows measurement of brain parenchymal concentrations
of small molecules : glucose, lactate, pyruvate, glutamate, glycerol,.... It's a tool to
evaluate the metabolic state of the brain divided into 4 categories : normal,
hyperglycolysis, ischemia and metabolic crisis.
Then, we will detail the effects of ketamine on metabolic state of the brain, especially
glutamate concentration. Normal values are below 10 micromol/ml. After head trauma it can
dramatically increase to values up to 50 or even 100 micromol/ml, with normalization after
24 hours. Ketamine is expected to decrease these high values faster than described in
observational studies.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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