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The Effects of Dexmedetomidine on the Heart Beat During Elective Surgery in Children (DexmedQT)

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.
 
ClinicalTrials.gov Identifier: NCT02353169
Recruitment Status : Completed
First Posted : February 2, 2015
Results First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Simon Whyte, University of British Columbia

Brief Summary:
Dexmedetomidine is a sedative drug that is commonly used to improve calmness and reduce pain in children waking up after surgery. Some of the side effects of dexmedetomidine, such as a potential change in how the heart muscles contract and changes in blood sugar and potassium levels, are poorly understood. The current study aims to examine these changes directly in healthy children undergoing elective surgery by measuring the heart beats (with an electrocardiogram) and blood sugar and potassium at specific times before and after dexmedetomidine is given. The investigators aim to establish a better understanding of this drug's safety profile.

Condition or disease Intervention/treatment Phase
Myocardial Repolarization Healthy Drug: Dexmedetomidine Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of Dexmedetomidine on Myocardial Repolarization in Children
Study Start Date : September 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Dexmedetomidine 0.25mcg/kg
0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Drug: Dexmedetomidine
Other Name: Precedex

Experimental: Dexmedetomidine 0.5mcg/kg
0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Drug: Dexmedetomidine
Other Name: Precedex

Experimental: Dexmedetomidine 0.75mcg/kg
0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Drug: Dexmedetomidine
Other Name: Precedex

Sham Comparator: Saline bolus
10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
Drug: Saline
Other Name: 9% NaCl




Primary Outcome Measures :
  1. Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention [ Time Frame: 60 seconds post-intervention ]
    Absolute QTc and TP-e values 1min after a bolus of dexmedetomidine or saline. Measured with 12-lead ECG.


Secondary Outcome Measures :
  1. Blood Glucose Levels at 15min and 30min Post-intervention [ Time Frame: over 30 minutes post-intervention ]
    Blood glucose levels at 15 min and 30 min after a bolus of dexmedetomidine or saline. Measured from 1 mL venous blood sample with blood gas analyzer.

  2. Blood Potassium Levels at 15min and 30min Post-intervention [ Time Frame: over 30 minutes post-intervention ]
    Blood potassium levels at 15 min and 30 min after a bolus of dexmedetomidine or saline. Measured from 1mL venous blood sample with blood gas analyzer



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA Physical Status I-II
  • Age 3 to 10yrs
  • Elective surgical procedure requiring general anesthesia
  • Use of dexmedetomidine acceptable to the staff anesthesiologist
  • Un-premedicated
  • Ability to read and understand English (parent/legal guardian(s) and child)

Exclusion Criteria:

  • Long QT syndrome (LQTS)
  • Cardiac disease or rhythm abnormalities
  • Family history of LQTS or abnormal cardiac conduction
  • Currently taking medications known to prolong QT
  • Currently taking medications known to predispose to hypokalemia
  • Known hypersensitivity to dexmedetomidine or other study medication
  • Weight < 5th centile or > 95th centile for age
  • Previously diagnosed hypokalemia
  • Impaired renal or liver function
  • Pre-operative anxiety requiring sedatives or opioids
  • Refusal to participate

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): NCT02353169


Locations
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Canada, British Columbia
BC Children's Hospital - Department of Anesthesia
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Simon Whyte, MBBS, FRCA BC Children's Hospital, Department of Anesthesia
  Study Documents (Full-Text)

Documents provided by Simon Whyte, University of British Columbia:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simon Whyte, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02353169    
Other Study ID Numbers: H14-03274
First Posted: February 2, 2015    Key Record Dates
Results First Posted: October 7, 2019
Last Update Posted: October 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Simon Whyte, University of British Columbia:
changes in myocardial repolarization in healthy children
Additional relevant MeSH terms:
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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