Comparing Safety and Efficacy of Dexmedetomidine and Propofol

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
MRI Sedation
Drug: Dexmedetomidine
Drug: Propofol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing Safety and Efficacy of Dexmedetomidine and Propofol in Patients Requiring Sedation for MRI Scanning

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 192
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine Group 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
Active Comparator: Propofol Group 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

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.

  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152021

Contacts
Contact: Randy Prescilla, MD 617-355-7184 randy.prescilla@childrens.harvard.edu
Contact: Vanessa Young, RN Vanessa.Young@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Randy Prescilla       randy.prescilla@childrens.harvard.edu   
Contact: Vanessa Young       vanessa.young@childrens.harvard.edu   
Principal Investigator: Randy Prescilla, MD         
Sub-Investigator: Keira Mason, MD         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Randy Prescilla, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Randy Prescilla, Assistant in Perioperative Anesthesia, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01152021     History of Changes
Other Study ID Numbers: 09-05-0250
Study First Received: June 25, 2010
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:
dexmedetomidine
propofol
sedation
MRI
scanning
pediatric
children
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 09, 2014