Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents
NCT ID: NCT02404779
Last Updated: 2020-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
34 participants
INTERVENTIONAL
2015-03-19
2022-06-18
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CISATRACURIUM
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.
cisatracurium besilate
PLACEBO
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.
Placebo
Interventions
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cisatracurium besilate
Placebo
Eligibility Criteria
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Inclusion Criteria
* Mechanical ventilation and deep sedation
* Severe traumatic brain injury
* Intracranial hypertension (ICP \> 20 mmHg during \> 15 minutes)
* Intracranial pressure monitoring
* Hemodynamically stable
Exclusion Criteria
* Hemodynamic instability
* Pregnant and/or breast feeding women
18 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Locations
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CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014-004951-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CHU-0225
Identifier Type: -
Identifier Source: org_study_id
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