The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children (DexMED)
Dexmedetomidine is a sedative drug that has many benefits when given to children under anesthesia, such as improved pain relief and reduced agitation following their surgery. It is usually given as an intravenous infusion over 10 minutes, to avoid the changes in heart rate and blood pressure that are occasionally seen when it is administered more quickly. However, this is often infeasible and usually inconvenient. The investigators aim to determine the dose of dexmedetomidine that can be given rapidly (over 5 seconds) without causing significant changes in heart rate and blood pressure. This will be the only study specific intervention.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children|
- Dose of dexmedetomidine [ Time Frame: 10 minutes for each patient ] [ Designated as safety issue: No ]Dose of dexmedetomidine that can be given as a rapid bolus that does not cause significant hemodynamic effects in healthy children
- BIS readings [ Time Frame: 10 minutes for each patient ] [ Designated as safety issue: No ]Requirement for rescue intervention, BIS readings before and after dexmedetomidine bolus
|Study Start Date:||January 2012|
|Study Completion Date:||September 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: Dexmedetomidine Rapid Bolus
All subjects will receive a rapid bolus of dexmedetomidine following induction of anesthesia with propofol and remifentanil and placement of laryngeal mask airway.
The bolus dose of dexmedetomidine given will range from 0.25-2.0 mcg/kg and will be based on the up-and-down method, such that subject 1 will receive 0.5 mcg/kg and if no significant hemodynamic changes occur (heart rate decrease < 20% or blood pressure decrease/increase < 20%) the does will be increased by 0.25 mcg/kg for the subsequent subject. If significant hemodynamic changes occur (HR decrease >/= 20% or SBP/DBP/MAP decrease or increase >/= 20%) the dose will be decreased by 0.25 mcg/kg for the subsequent subject. Each subject will be observed for 10 minutes following the dexmedetomidine bolus.
Other Name: Precedex
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01498380
|Canada, British Columbia|
|British Columbia Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|