Traumatic Brain Injury Clinical Trial
Official title:
Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study Versus Placebo
Severely brain injured patients are at high risk of intracranial hypertension. Among medical
treatments (sedatives), neuromuscular blocking agents (NMBA) are recommended by french but
not english speaking societies.
Effects of NMBA are unknown. The present study is designed to compare the effects of NMBA
versus placebo in the treatment of intracranial hypertension, and the underlying
physiopathologic effects.
In case of intracranial hypertension, french neurocritical care society argue for the use of
neuromuscular blocking agents before osmotherapy, barbituric coma, hypothermia and
craniectomy.
English speaking societies don't sustain this approach. Since then, the use of NMBA remains
controversial in case of intracranial hypertension and no study is available.
We propose to study severely brain injured patients presenting with intracranial hypertension
and treat them with cisatracurium besilate or placebo.
Our hypothesis is that neuromuscular blockade might act on several parameters:
- Hemodynamics
- respiratory parameters, mechanical ventilation and blood gaz analysis
- cerebral velocities
- diminished O2 peripheral consumption
- cerebrospinal diffusion and concentration of cisatracurium and a metabolite laudanosine
We wish to assess changes in ICP according to the above parameters in a controlled
randomized non blinded fashion against placebo (NaCl 0,9%).
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