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

Not Applicable

Completed

• Conditions: Withdrawal Syndrome; Cerebral Lesion
• Interventions: Other: Variation of Jasinski score between H0 (stop of sedatives) and H6

• Registration Number: NCT03114904
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-27
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Primary Completion: 2018-05-16
• Study Completion: 2018-05-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Introduction to H2 for the discontinuation of therapeutics	Variation of Jasinski score between H0 (stop of sedatives) and H6	-
"Usual" weaning management	Variation of Jasinski score between H0 (stop of sedatives) and H6	-

Primary Outcome Measures

Name	Time	Method
A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal	3 months

Trial Locations

Locations (1)

CHU Amiens Picardie; 🇫🇷 Amiens, Picardie, France