Comparing Safety and Efficacy of Dexmedetomidine and Propofol

Boston Children's Hospital

Status and phase: Terminated; Phase 3

Conditions: Safety and Efficacy of Sedation Medications

Treatments: Drug: Propofol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01152021

09-05-0250

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 15 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Dexmedetomidine Group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Propofol Group

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol