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

NCT06203522 | Completed

• 1 other identifier: 2023-12'Obs-CHRMT
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Sedation; EEG; MRI

Keywords

Dexmedetomidin; procedural sedation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Procedure: Data collection of successful completion of MRI

Interventions

Data collection of successful completion of MRI PROCEDURE

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

MRI with Dexmedetomidin

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• incomplete or missing medical records

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital Mercy

Metz, 57085, France

Location

Study Officials

• Anne Charlotte CULLIER, MD

  CHR Metz Thionville Hopital Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: January 1, 2024
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)