Comparing Safety and Efficacy of Dexmedetomidine and Propofol

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Safety and Efficacy of Sedation Medications

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine Group<br>Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol. | Drug: Dexmedetomidine<br>* 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.<br>* Other names: Precedex;|
| Active Comparator: Propofol Group<br>Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to two additional 1 mg/kg boluses may be administered (total 3 mg/kg) - each over a one (1) minute interval, waiting 30 seconds after completion of each bolus to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg. | Drug: Propofol<br>* 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.<br>* Other names: Diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events During the Sedation and Recovery Period | Adverse events will be described by type, system involvement and level of severity. | During sedation, recovery period and overnight, up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations) | Sedation scores, mean arterial blood pressures, clinical observations during sedation and recovery period | During sedation, recovery and overnight, up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, children, dexmedetomidine, propofol, sedation, scanning, pediatric, Magnetic Resonance Imaging