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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete.
An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete.
Children's Hospital Boston
Boston, Massachusetts, United States
Number of Adverse Events During the Sedation and Recovery Period
Adverse events will be described by type, system involvement and level of severity.
Time frame: During sedation, recovery period and overnight, up to 24 hours
Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations)
Sedation scores, mean arterial blood pressures, clinical observations during sedation and recovery period
Time frame: During sedation, recovery and overnight, up to 24 hours
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