NCT03114904

Completed

Comparison of the Efficacy of a Protocol for the Withdrawal ...

Centre Hospitalier Universitaire, Amiens Source

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Other study identifiers

Sponsor study identifier

PI2015_843_0019

Study Type

interventional

Actual enrollment (reported)

8

Locations

1 country

Sites

1

Timeline

Study Start

February 27, 2016

Actual (reported)

Primary Completion

May 16, 2018

Actual (reported)

Study Completion

May 16, 2018

Actual (reported)

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).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 8 participants
Study completion date: May 16, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 27, 2016
Actual (reported)
First Submitted
April 4, 2017
Actual (reported)
First Posted
April 14, 2017
Actual (reported)
Primary Completion
May 16, 2018
Actual (reported)
Study Completion
May 16, 2018
Actual (reported)

Last Updated: July 20, 2020
Status Verified: July 2020
Last Update Submitted: July 17, 2020

Conditions

Cerebral Lesion Withdrawal Syndrome

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Major Patient
Admitted in Neuroreanimation

Sponsors & Collaborators

Centre Hospitalier Universitaire, Amiens
Otherlead

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Enrollment

8 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT04639401

Auditory-motor Coupling in Multiple Sclerosis With Cerebellar Lesions

Not ApplicableCompleted

NCT05477316

A Study to Assess the Efficacy of Cerebellar IMRT Combined With Cerebral SRS in Patients With Brain Metastases

Not ApplicableUnknown

NCT05883358

Kratom Use Disorder Management Using Clonidine and/or Buprenorphine

Recruiting

NCT03645603

Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01)

Phase 2Terminated

NCT03996096

Tyrosine Kinase Inhibitor Withdrawal Syndrome in CML Patients: Observatory Trial Studying the Biological Factors.

Completed

NCT05391282

Internal Carotid Artery Blood Flow in Infants With Prone Position

Unknown

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.

Primary Completion

May 16, 2018

Actual (reported)

Study Completion

May 16, 2018

Actual (reported)

Last Updated

July 20, 2020

Record last verified: 2020-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03114904
Data provider: ClinicalTrials.gov
Source updated: 2020-07-20
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:27:05 UTC

Locations

FR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

"Usual" weaning management

Introduction to H2 for the discontinuation of therapeutics

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations