Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses

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).

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Key information

Conditions

Withdrawal Syndrome Cerebral Lesion Chemically-Induced Disorders Mental Disorders Substance Withdrawal Syndrome Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Variation of Jasinski score between H0 (stop of sedatives) and H6

Other

To compare the effectiveness of a withdrawal management protocol with the usual management in cerebral patients (Subarachnoid haemorrhage (HSA), stroke and head trauma (CT))

Primary outcomes

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

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: NEUROSEV

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Apr 14, 2017
Registry last updated: Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed