Comparing Safety and Efficacy of Dexmedetomidine and Propofol

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Dexmedetomidine; Propofol

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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