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

NCT ID: NCT03114904

Last Updated: 2020-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-27
• Study Completion Date: 2018-05-16

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).

Conditions

Withdrawal Syndrome; Cerebral Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

"Usual" weaning management

Group Type: OTHER

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

Intervention Type: 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))

Introduction to H2 for the discontinuation of therapeutics

Group Type: OTHER

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

Intervention Type: 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))

Interventions

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))

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Amiens Picardie

Amiens, Picardie, France

Countries

France

Other Identifiers

PI2015_843_0019

Identifier Type: -

Identifier Source: org_study_id