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Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin

Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin: an Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06203522
Acronym
RIDEX
Enrollment
81
Registered
2024-01-12
Start date
2024-01-01
Completion date
2024-03-30
Last updated
2024-08-09

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

Conditions

EEG, MRI, Procedural Sedation

Keywords

Dexmedetomidin, procedural sedation

Brief 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.

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.

Interventions

PROCEDUREData collection of successful completion of MRI

age, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure

Sponsors

Centre Hospitalier Régional Metz-Thionville
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 18 Years

Inclusion criteria

* patients under 18 years of age sedated with DEX IN prior to MRI.

Exclusion criteria

* incomplete or missing medical records

Design outcomes

Primary

MeasureTime frameDescription
Successful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images.Immediately after procedureSuccessful Completion of MRI, defined as the radiologist having no reservations about the interpretation of the images (yes/no)

Countries

France

Outcome results

None listed

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