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The Effects of the Anesthetic Drug Propofol on the Way the Heart Recovers Between Beats

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. Identifier: NCT00358618
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : August 18, 2009
Information provided by:
University of British Columbia

Brief Summary:
We are investigating a new technique for testing the effect of drugs on electrical activity in the heart. Disturbances of this electrical activity can cause life-threatening changes to heart rhythms. A better way of measuring the risk has recently been developed, and our research team leads the world in using this tool to test the safety of drugs used in children. Children and their families want to know that the drugs being used are safe, as do the doctors that care for them. In this study, we will take heartbeat tracings (ECGs) from 60 children before and during their operations. The ECGs will then be checked by a children's heart specialist. Differences on the ECGs will be related to the presence and amount of drug (propofol) given. We expect that the propofol will not cause any changes that show increased risk of abnormal heart rhythms. We can then tell patients, parents and regulatory authorities of the safety profile of this aspect of the drug; moreover, the study can be used as a model for testing many other drugs used in hospitals.

Condition or disease Intervention/treatment Phase
Myocardial Repolarization Drug: Propofol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Three Effect-site-targeted Propofol Concentrations on Dispersion of Myocardial Repolarization in Children
Study Start Date : September 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Intervention Details:
  • Drug: Propofol
    See Detailed Description.

Primary Outcome Measures :
  1. Change in Tpeak-end interval before & after intervention & between groups.

Secondary Outcome Measures :
  1. Change in QT intervals before & after intervention & between groups.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Health children (ASA I-II) undergoing procedures that require general anesthesia without pre-medication.

Exclusion Criteria:

  • Children with long QT syndrome, a family history of long QT syndrome or taking medication that is known to prolong the QT interval.
  • IV access unobtainable pre-operatively.

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 identifier (NCT number): NCT00358618

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Canada, British Columbia
British Columbia Children's Hospital, Anesthesia Dept.
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
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Principal Investigator: Simon Whyte The University of British Columbia
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Responsible Party: Dr. Simon Whyte, University of British Columbia Identifier: NCT00358618    
Other Study ID Numbers: C06-0219
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009
Keywords provided by University of British Columbia:
3-group clinical interventional study
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General