Status:
TERMINATED
Comparing Safety and Efficacy of Dexmedetomidine and Propofol
Lead Sponsor:
Boston Children's Hospital
Conditions:
Safety and Efficacy of Sedation Medications
Eligibility:
All Genders
3-11 years
Phase:
PHASE3
Brief 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 impo...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01152021
Start Date
August 1 2011
End Date
July 1 2014
Last Update
May 21 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115