NCT03114904

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

2.2 years

First QC Date

April 4, 2017

Last Update Submit

July 17, 2020

Conditions

Withdrawal SyndromeCerebral Lesion

Outcome Measures

Primary Outcomes (1)

  • A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal

    3 months

Study Arms (2)

"Usual" weaning management

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

Introduction to H2 for the discontinuation of therapeutics

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

Interventions

Variation of Jasinski score between H0 (stop of sedatives) and H6OTHER

To compare the effectiveness of a withdrawal management protocol with the usual management in cerebral patients (Subarachnoid haemorrhage (HSA), stroke and head trauma (CT))

"Usual" weaning managementIntroduction to H2 for the discontinuation of therapeutics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

Location

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2017

First Posted

April 14, 2017

Study Start

February 27, 2016

Primary Completion

May 16, 2018

Study Completion

May 16, 2018

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations

FR(1)