Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents (THIC Cu)

University Hospital, Clermont-Ferrand

Status and phase: Unknown; Phase 4

Conditions: Traumatic Brain Injury; Intracranial Hypertension

Treatments: Drug: cisatracurium besilate; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02404779

CHU-0225

2014-004951-30 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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%).

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Age over 18
• Mechanical ventilation and deep sedation
• Severe traumatic brain injury
• Intracranial hypertension (ICP > 20 mmHg during > 15 minutes)
• Intracranial pressure monitoring
• Hemodynamically stable

Exclusion criteria

• • History of anaphylaxia with neuromuscular agents
• Hemodynamic instability
• Pregnant and/or breast feeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups, including a placebo group

CISATRACURIUM

Experimental group

Description:

To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.

Treatment:

Drug: cisatracurium besilate

PLACEBO

Placebo Comparator group

Description:

To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.

Treatment:

Other: Placebo