Brief Summary

This study aims to assess the use of intranasal dexmedetomidine (IN-dex) as a sole agent in aiding the successful completion of a MRI scans in children. Dexmedetomidine, a routinely used anesthetic agent in our institution, has many benefits including sedation with neuro-protective and respiratory sparing features. We will test its effectiveness in completing MRI scans in children that would otherwise be given a full general anesthetic.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

180

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Feb 2019

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

January 14, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed

16 days until next milestone

Study Start

First participant enrolled

February 1, 2019

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed

Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

1.1 years

First QC Date

January 14, 2019

Last Update Submit

January 23, 2019

Conditions

MRI Sedation

Keywords

dexmedetomidine

Outcome Measures

Primary Outcomes (1)

Dose
The intranasal dexmedetomidine dose in mcg/kg that produces successful completion of MRI scan with acceptable MRI image quality in 90% of individuals (ED 90).
Immediately after completion of the MRI scan.

Secondary Outcomes (4)

Uninterrupted scans
Immediately after completion of the MRI scan.
Respirator support
During MRI scan
Adverse events
During MRI scan
modified Yale Preoperative Anxiety Scale (mYPAS)
Immediately before administration of intranasal dexmedetomidine

Study Arms (1)