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The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children (DexMED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01498380
First received: December 20, 2011
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Hemodynamic Instability
Drug: Dexmedetomidine

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 21
Study Start Date: January 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Dexmedetomidine
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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  Eligibility

Ages Eligible for Study:   5 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I-II patients
  • Elective surgery
  • Planned general anesthesia with TIVA
  • Planned insertion of LMA
  • Ages ≥ 5 to < 10 years

Exclusion Criteria:

  • Cardiac disease
  • Cardiac rhythm abnormalities
  • Chronic hypertension
  • Predicted difficult intubation
  • Contraindication to LMA use
  • Weight < 5th centile or > 95th centile for age
  • Pre-operative administration of anxiolytics (such as benzodiazepines or opioid analgesics)
  • Hypersensitivity to dexmedetomidine or any other study medication
  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: NCT01498380

Locations
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01498380     History of Changes
Other Study ID Numbers: H11-03137
Study First Received: December 20, 2011
Last Updated: February 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Dexmedetomidine
Precedex
TIVA
Rapid bolus

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

ClinicalTrials.gov processed this record on November 27, 2014