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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03114904
Other study ID # PI2015_843_0019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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