Withdrawal SyndromeNEUROSEVNCT03114904
Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses
A study testing Variation of Jasinski score between H0 (stop of sedatives) and H6 in people with Withdrawal Syndrome and Cerebral Lesion, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Withdrawal Syndrome, Cerebral Lesion
- What is being tested?
- Variation of Jasinski score between H0 (stop of sedatives) and H6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2016to 16 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.
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).
- Conditions
- Withdrawal Syndrome, Cerebral Lesion
- Being tested
- Variation of Jasinski score between H0 (stop of sedatives) and H6
- Medical subject headings
- Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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))
| Study group | Role | What they receive |
|---|---|---|
| "Usual" weaning management | Other | Not described Receives: Other: Variation of Jasinski score between H0 (stop of sedatives) and H6 |
| Introduction to H2 for the discontinuation of therapeutics | Other | Not described Receives: Other: Variation of Jasinski score between H0 (stop of sedatives) and H6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start27 Feb 2016
- Primary completion16 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114904
- Sponsor's protocol ID
- PI2015_843_0019
- Acronym
- NEUROSEV
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2017
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of a Protocol for the Withdrawal of Neurosedation From the Usual Strategy in Cerebroses: Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03114904
- Acronym / sponsor ID
- NEUROSEV / PI2015_843_0019
- Conditions
- Withdrawal Syndrome, Cerebral Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 27 Feb 2016 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Addiction to opiates, cocaine or cannabis
- Neurological Pathology Before Hospitalization
- Patient suffering from cardiac arrest
- Pregnant woman
- Sedation window
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Variation of Jasinski score between H0 (stop of sedatives) and H6To compare the effectiveness of a withdrawal management protocol with the usual management in cerebral patients (Subarachnoid haemorrhage (HSA), stroke and head trauma (CT)) | Other | "Usual" weaning management, Introduction to H2 for the discontinuation of therapeutics |
Primary outcome
A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variation of Jasinski score between H0 (stop of sedatives) and H6 in people with Withdrawal Syndrome and Cerebral Lesion, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A variation of the Jasinski score between H0 (stop sedation) and H6. This score measures the signs of withdrawal (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.