Procedural SedationRIDEXNCT06203522
Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin
An observational study of Procedural Sedation and EEG, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
This is a retrospective cohort study aiming to determine whether the use of Dexmedetomidine (DEX) to sedate children prior to MRI scanning is more or less effective in children with autism spectrum disorders or other neurodevelopmental disorders compared to other children. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Procedural Sedation, EEG, MRI
- What is being tested?
- Data collection of successful completion of MRI
- Type of treatment
- Surgery or procedure
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 30 Mar 2024
- Phase
- Observational
- 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 3 months to 18 years
- All sexes
- Child, Adult
Study population: patients under 18 years of age sedated with DEX IN prior to MRI.
Who may be able to join
- patients under 18 years of age sedated with DEX IN prior to MRI.
Who cannot join
- incomplete or missing medical records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin: an Observational Study
This is a retrospective cohort study aiming to determine whether the use of Dexmedetomidine (DEX) to sedate children prior to MRI scanning is more or less effective in children with autism spectrum disorders or other neurodevelopmental disorders compared to other children.
Read the detailed description
Performing brain MRI on children under 5, or in cases of autism or disability, is often complex. In fact, this examination requires total immobilization of the child for at least 20 minutes. The noise and the fact that the child is lying in a sort of tunnel add to the child's stress.
General anesthesia with propofol is widely used in France, but requires invasive orotracheal intubation or mask ventilation. There are no national or international recommendations for pediatric MRI sedation procedures.
Intranasal dexmedetomidine (DEX) is used for brain MRI, cardiac ultrasound, ophthalmology, dental treatment and brain computed tomography (CT) in patients aged 3 months to 12 years. Its superior efficacy has been demonstrated in a number of studies compared with the most commonly used medicated procedural sedation techniques, but only one study in France has prospectively analyzed the efficacy of DEX IN for performing cerebral MRIs, but without assessing efficacy and tolerance in subgroups of children: with or without neurodevelopmental disorders, epilepsy, autism, age.
- Conditions
- Procedural Sedation, EEG, MRI
- Being tested
- Data collection of successful completion of MRI
- Keywords
- Dexmedetomidin, procedural sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection of successful completion of MRIProcedure or surgery
age, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure
| Study group | Role | What they receive |
|---|---|---|
| MRI with Dexmedetomidin | Mean age is compared between the "pass" and "fail" groups using a Student's t-test accounting for inequality of variances. MRI success rates are compared between subgroups using Fischer's exact tests. Finally, factors related to MRI success rates are investigated using multivariate logistic regression, including all the factors described above. Receives: Procedure: Data collection of successful completion of MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images.
Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images (yes/no)
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural SedationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Charlotte CULLIER, MD, Principal investigator, CHR Metz Thionville Hopital Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203522
- Sponsor's protocol ID
- 2023-12'Obs-CHRMT
- Acronym
- RIDEX
- Status last verified
- Aug 2024
- First submitted
- 3 Jan 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the French law and the French Data Protection Authority (CNIL), it is not possible to share publicly individual participant data, but only their conclusions through peer-reviewed publications and conferences.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin: an Observational Study
- ClinicalTrials.gov ID
- NCT06203522
- Acronym / sponsor ID
- RIDEX / 2023-12'Obs-CHRMT
- Conditions
- Procedural Sedation, EEG, MRI
- Keywords
- Dexmedetomidin, procedural sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 12 Jan 2024 (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.
This is a retrospective cohort study aiming to determine whether the use of Dexmedetomidine (DEX) to sedate children prior to MRI scanning is more or less effective in children with autism spectrum disorders or other neurodevelopmental disorders compared to other children.
Detailed description
Performing brain MRI on children under 5, or in cases of autism or disability, is often complex. In fact, this examination requires total immobilization of the child for at least 20 minutes. The noise and the fact that the child is lying in a sort of tunnel add to the child's stress.
General anesthesia with propofol is widely used in France, but requires invasive orotracheal intubation or mask ventilation. There are no national or international recommendations for pediatric MRI sedation procedures.
Intranasal dexmedetomidine (DEX) is used for brain MRI, cardiac ultrasound, ophthalmology, dental treatment and brain computed tomography (CT) in patients aged 3 months to 12 years. Its superior efficacy has been demonstrated in a number of studies compared with the most commonly used medicated procedural sedation techniques, but only one study in France has prospectively analyzed the efficacy of DEX IN for performing cerebral MRIs, but without assessing efficacy and tolerance in subgroups of children: with or without neurodevelopmental disorders, epilepsy, autism, age.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI with Dexmedetomidin | – | Procedure: Data collection of successful completion of MRIMean age is compared between the "pass" and "fail" groups using a Student's t-test accounting for inequality of variances. MRI success rates are compared between subgroups using Fischer's exact tests. Finally, factors related to MRI success rates are investigated using multivariate logistic regression, including all the factors described above. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients under 18 years of age sedated with DEX IN prior to MRI.
Key inclusion criteria (1 listed)
- patients under 18 years of age sedated with DEX IN prior to MRI.
Key exclusion criteria (1 listed)
- incomplete or missing medical records
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 |
|---|---|---|
| Data collection of successful completion of MRIage, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure | Procedure or surgery | MRI with Dexmedetomidin |
Primary outcome
Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images.
Time frame: Immediately after procedure
Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images (yes/no)
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 9 Aug 2024.
- Individual participant dataSharing planned: No. According to the French law and the French Data Protection Authority (CNIL), it is not possible to share publicly individual participant data, but only their conclusions through peer-reviewed publications and conferences.
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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.
Anne Charlotte CULLIER, MD principal investigator
CHR Metz Thionville Hopital Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Procedural Sedation and EEG, run by Centre Hospitalier Régional Metz-Thionville 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 1 inclusion and 1 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 9 Aug 2024. 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?
Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images. (time frame: Immediately after procedure). 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 9 Aug 2024.