跳至主要内容
临床试验/NCT03114904
NCT03114904已完成不适用

Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2016年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal

研究概览

简要总结

The withdrawal syndrome in benzodiazepines and morphine is common in intensive care, the incidence is estimated at 32.1%.

Cerebrospatized patients are probably more prone to withdrawal because they require high doses of sedation.

Moreover, this syndrome is probably deleterious on the cerebral hemodynamics (high point of the therapeutic management).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • •Major Patient
  • •Admitted in Neuroreanimation
  • •Cerebroséé (TC-HSA-AVC)
  • •Mono or multi failing
  • •After a neurosedation ≥ 3 days by hypnotic type benzodiazepine (Midazolam®) and morphinomimetic (Sufentanyl®) in IVSE
  • •Affiliation to Social Security
  • •Agreement of the person of confidence

排除标准

  • •Addiction to opiates, cocaine or cannabis
  • •Neurological Pathology Before Hospitalization
  • •Patient suffering from cardiac arrest
  • •Pregnant woman
  • •Sedation window
  • •Patient under tutelage or curatorship or deprived of public law

研究组 & 干预措施

"Usual" weaning management

Other

干预措施: Variation of Jasinski score between H0 (stop of sedatives) and H6 (Other)

Introduction to H2 for the discontinuation of therapeutics

Other

干预措施: Variation of Jasinski score between H0 (stop of sedatives) and H6 (Other)

结局指标

主要结局

A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal

时间窗: 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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