Treatment of Intracranial Hypertension of Severe Tramatic Brain Injured Patients. Physiopathologic Effects of Neuromuscular Blocking Agents. A Controlled Randomized Study Versus Placebo
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- area under the curve of the temporal evolution of intracranial pressure
研究概览
简要总结
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.
详细描述
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%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- History of anaphylaxia with neuromuscular agents
- •Hemodynamic instability
- •Pregnant and/or breast feeding women
研究组 & 干预措施
CISATRACURIUM
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.
干预措施: cisatracurium besilate (Drug)
PLACEBO
To compare the evolution of intracranial pressure (ICP) of severely brain injured patients with intracranial hypertension after administration of cisatracurium versus placebo.
干预措施: Placebo (Other)
结局指标
主要结局
area under the curve of the temporal evolution of intracranial pressure
时间窗: at day 1
The primary outcome is the area under the curve of the temporal evolution of intracranial pressure, over a period of 30 minutes after the administration of neuromuscular blocking agent or placebo.
次要结局
- Need to increase therapeutics(at day 1)
- Course of intracranial and cerebral perfusion pressures and various cerebral monitoring data if available (SvjO2, PtiO2)(at day 1)
- Monitoring of the time spent by intracranial pressure above 20 mmHg using continuous recording(at day 1)
- Course of transcranial Doppler data(at day 1)
- Course of arterial blood gas data(at day 1)
- Occurrence of renal complications(at day 1)
- Occurrence of infectious complications(at day 1)
- Course of ventilation parameters(at day 1)
- Cerebrospinal fluid concentrations of cisatracurium and laudanosin in case of cerebrospinal fluid derivation(at day 1)
- Occurrence of cardiovascular complications(at day 1)
- Occurrence of pulmonary complications(at day 1)
- Course of intracranial pressure based on the type of brain injury(at day 1)
- Monitoring of the curare effect(at day 1)
- Course of plasma and cerebrospinal fluid concentrations of cistracurium and laudanosine(at day 1)
- Doses of vasopressors or catecholamines(at day 1)