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

Withdrawal Syndrome Clinical Trial

— NEUROSEV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03114904
• Other study ID #: PI2015_843_0019
• Status: Completed
• Phase: N/A
• Start date: February 27, 2016
• Est. completion date: May 16, 2018

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Lesion
• Substance Withdrawal Syndrome
• Withdrawal Syndrome

Intervention

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))

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal		3 months