Comparing Safety and Efficacy of Dexmedetomidine and Propofol

This study has been terminated.
(Publication of a similar study. Not ethical to continue.)
Sponsor:
Information provided by (Responsible Party):
Randy Prescilla, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01152021
First received: June 25, 2010
Last updated: July 17, 2014
Last verified: July 2014
  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
Safety and Efficacy of Sedation Medications
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 ]

Enrollment: 15
Study Start Date: August 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine Group
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
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
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
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

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
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: July 17, 2014
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 20, 2014