Comparing Safety and Efficacy of Dexmedetomidine and Propofol

Safety and Efficacy of Sedation Medications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01152021
• Other study ID #: 09-05-0250
• Status: Terminated
• Phase: Phase 3
• Start date: August 2011
• Est. completion date: July 2014

Study information

• Verified date: May 2019
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Safety and Efficacy of Sedation Medications

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events During the Sedation and Recovery Period	Adverse events will be described by type, system involvement and level of severity.	During sedation, recovery period and overnight, up to 24 hours
Secondary	Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations)	Sedation scores, mean arterial blood pressures, clinical observations during sedation and recovery period	During sedation, recovery and overnight, up to 24 hours