Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin
NCT ID: NCT06203522
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
81 participants
OBSERVATIONAL
2024-01-01
2024-03-30
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
Data collection of successful completion of MRI
age, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure
Interventions
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Data collection of successful completion of MRI
age, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional Metz-Thionville
OTHER
Responsible Party
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Principal Investigators
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Anne Charlotte CULLIER, MD
Role: PRINCIPAL_INVESTIGATOR
CHR Metz Thionville Hopital Mercy
Locations
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CHR Metz-Thionville/Hopital Mercy
Metz, , France
Countries
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Other Identifiers
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2023-12'Obs-CHRMT
Identifier Type: -
Identifier Source: org_study_id
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