Utility of Oral Dexmedetomidine as the Sole Sedative Agent in Pediatric Population Undergoing MRI

NCT05619627 Phase 1 NOT_YET_RECRUITING

The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.

Details

Lead sponsor	Soroush Merchant
Phase	Phase 1
Status	NOT_YET_RECRUITING
Enrolment	18
Start date	2026-06-01
Completion	2027-09

Conditions

• Anesthesia

Interventions

• Dexmedetomidine
• General Anesthesia (control group)

Primary outcomes

• Oral dexmedetomidine dose with adverse event below moderate risk, as designated by SIVA, to obtain adequate MRI study — From date of the first enrollment until the end of assessment of data collected from the last participant, up to 70 weeks
  The primary outcome is determining a dose of oral dexmedetomidine that will safely (adverse event (AE) below moderate risk, as designated by the World Society of Intravenous Anesthesia (SIVA) adverse sedation event reporting tool) provide adequate sedation to successfully complete an MRI. Images should have adequate quality and resolution to be interpretated and will be graded by an attending radiologist. Each MRI sequence will be graded 1-3. 1: no-mild motion artifact; 2: moderate motion artifact; 3: severe motion artifact (non-diagnostic).

Countries

United States