NCT01152021

Comparing Safety and Efficacy of Dexmedetomidine and Propofol

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

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 important patient demographics and looking at important outcomes including adverse events.

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 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.

Conditions

• Safety and Efficacy of Sedation Medications

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	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.
DRUG	Propofol	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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-06-29
• Last updated: 2019-05-21
• Results posted: 2019-05-21

Locations

1 site across 1 country: United States