Comparing Safety and Efficacy of Dexmedetomidine and Propofol



Status:Terminated
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:3 - 11
Updated:12/15/2017
Start Date:August 2011
End Date:July 2014

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Trial Summary
Trial Overview
Inclusion Criteria

Comparing Safety and Efficacy of Dexmedetomidine and Propofol in Patients Requiring Sedation for MRI Scanning

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.

Patients will be randomized to either arm of the study. Throughout the sedation and recovery
period, all study patients will have careful, routine documentation of hemodynamics (blood
pressure, heart rate, plus oximeter, respiratory rate) as well as sedation depth. Patients
will remain in recovery room until they have maintained discharge criteria for 30 minutes.

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
We found this trial at
1
site
Children's Hospital Boston
Boston, Massachusetts 02115
?
mi
from
Boston, MA
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