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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03114904
Acronym
NEUROSEV
Enrollment
8
Registered
2017-04-14
Start date
2016-02-27
Completion date
2018-05-16
Last updated
2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Lesion, Withdrawal Syndrome

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).

Interventions

OTHERVariation 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))

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026