Comparing Safety and Efficacy of Dexmedetomidine and Propofol

This study is currently recruiting participants.
Verified September 2012 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Randy Prescilla, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01152021
First received: June 25, 2010
Last updated: September 14, 2012
Last verified: September 2012

June 25, 2010
September 14, 2012
August 2011
December 2013   (final data collection date for primary outcome measure)
Number of adverse events during the sedation and recovery period as a measure of safety and tolerability. [ Time Frame: 6 - 8 months ] [ Designated as safety issue: Yes ]
Adverse events will be described by type and level of severity.
Same as current
Complete list of historical versions of study NCT01152021 on ClinicalTrials.gov Archive Site
To compare propofol and dexmedetomidine with respect to clinical parameters (sedation scales, hemodynamic variables, clinical observations) [ Time Frame: 6 - 8 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Comparing Safety and Efficacy of Dexmedetomidine and Propofol
Comparing Safety and Efficacy of Dexmedetomidine and Propofol in Patients Requiring Sedation for MRI Scanning

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
MRI Sedation
  • 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.
    Other Name: Precedex
  • 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.
    Other Name: Diprivan
  • Active Comparator: Dexmedetomidine Group
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: Propofol Group
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
192
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
3 Years to 11 Years
No
Contact: Randy Prescilla, MD 617-355-7184 randy.prescilla@childrens.harvard.edu
Contact: Vanessa Young, RN Vanessa.Young@childrens.harvard.edu
United States
 
NCT01152021
09-05-0250
Yes
Randy Prescilla, Children's Hospital Boston
Children's Hospital Boston
Not Provided
Principal Investigator: Randy Prescilla, MD Children's Hospital Boston
Children's Hospital Boston
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP