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

Primary Purpose

Withdrawal Syndrome, Cerebral Lesion

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Variation of Jasinski score between H0 (stop of sedatives) and H6
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Withdrawal Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens Picardie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

"Usual" weaning management

Introduction to H2 for the discontinuation of therapeutics

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 4, 2017
Last Updated
July 17, 2020
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT03114904
Brief Title
Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses
Acronym
NEUROSEV
Official Title
Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 27, 2016 (Actual)
Primary Completion Date
May 16, 2018 (Actual)
Study Completion Date
May 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Withdrawal Syndrome, Cerebral Lesion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
"Usual" weaning management
Arm Type
Other
Arm Title
Introduction to H2 for the discontinuation of therapeutics
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Variation of Jasinski score between H0 (stop of sedatives) and H6
Intervention Description
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 Measure Information:
Title
A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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