Comparing Safety and Efficacy of Dexmedetomidine and Propofol

Stopped early · Phase 3

Conditions studied: Safety and Efficacy of Sedation Medications

In brief

This is a prospective, open label randomized study. The purpose of this study is to compare propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically identifying important patient demographics and looking at important outcomes including adverse events.

Key facts

Study ID

NCT01152021

Run by

Boston Children's Hospital

People needed

15

Starts

2011-08-01

Expected to finish

2014-07-01

Last updated by the study team

2019-05-21

Who can join

Age: 3 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is 3 - 11 years
• Patient is scheduled for MRI at Children's Hospital Boston.
• Patient meets criteria to receive either dexmedetomidine or propofol sedation
• Patient's guardian provides written consent

You may not qualify if…

• Patient does not meet established sedation criteria
• Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
• Patient has current, repaired, or risk for Moya-Moya disease
• Patient has had a stroke within the past six months
• Patient has uncontrolled hypertension
• Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker
• Known soy, Lecithin, or egg allergy

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.