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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01498380
First Posted: December 23, 2011
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carolyne Montgomery, University of British Columbia
  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: Intervention Model: Single Group Assignment
Masking: None (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 Carolyne Montgomery, University of British Columbia:

Primary Outcome Measures:
  • Dose of dexmedetomidine [ Time Frame: 10 minutes for each patient ]
    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 ]
    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

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   5 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Carolyne Montgomery, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01498380     History of Changes
Other Study ID Numbers: H11-03137
First Submitted: December 20, 2011
First Posted: December 23, 2011
Last Update Posted: July 5, 2017
Last Verified: February 2014

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

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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