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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114904
Recruitment Status : Unknown
Verified May 2017 by Centre Hospitalier Universitaire, Amiens.
Recruitment status was:  Recruiting
First Posted : April 14, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Withdrawal Syndrome Cerebral Lesion Other: Variation of Jasinski score between H0 (stop of sedatives) and H6 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.
Actual Study Start Date : February 27, 2016
Estimated Primary Completion Date : May 16, 2018
Estimated Study Completion Date : May 16, 2018

Arm Intervention/treatment
"Usual" weaning management Other: Variation of Jasinski score between H0 (stop of sedatives) and H6
To compare the effectiveness of a withdrawal management protocol with the usual management in cerebral patients (Subarachnoid haemorrhage (HSA), stroke and head trauma (CT))

Introduction to H2 for the discontinuation of therapeutics Other: Variation of Jasinski score between H0 (stop of sedatives) and H6
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 Outcome Measures :
  1. A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114904


Contacts
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Contact: Alexis SALOMON, Dr +33322087868 salomon.alexis@chu-amiens.fr

Locations
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France
CHU Amiens Picardie Recruiting
Amiens, Picardie, France, 80054
Contact: Alexis SALOMON, Dr    +33322087868    salomon.alexis@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03114904    
Other Study ID Numbers: PI2015_843_0019
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs