NCT02404779

Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents

Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study Versus Placebo

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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%).

Conditions

• Traumatic Brain Injury
• Intracranial Hypertension

Interventions

Type	Name	Description
DRUG	cisatracurium besilate
OTHER	Placebo

Timeline

• Start date: 2015-03-19
• Primary completion: 2022-03-19
• Completion: 2022-06-18
• First posted: 2015-04-01
• Last updated: 2020-07-07

Locations

1 site across 1 country: France