Expired Study
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Boston, Massachusetts 02115


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT01152021


Primary Contact:

Principal Investigator
Randy Prescilla, MD
Boston Children’s Hospital


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02115
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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