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

MRI Clinical Trial

— RIDEX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203522
• Other study ID #: 2023-12'Obs-CHRMT
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: March 1, 2024

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Arpiné EL NAR, PhD
• Phone: 0033387557766
• Email: arpine.el-nar[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• incomplete or missing medical records

Related Conditions & MeSH terms

• EEG
• MRI
• Procedural Sedation

Intervention

Procedure:
• Data collection of successful completion of MRI
age, sex, autistic disorders, epilepsy, polyhandicap, non-autistic neurodevelopmental disorders, success of MRI procedure

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital Mercy	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Immediately after procedure