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

This study has been completed.
Sponsor:
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00358618
First received: July 28, 2006
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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 Intervention
Myocardial Repolarization
Drug: Propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Three Effect-site-targeted Propofol Concentrations on Dispersion of Myocardial Repolarization in Children

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Change in Tpeak-end interval before & after intervention & between groups. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in QT intervals before & after intervention & between groups. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Propofol
    See Detailed Description.
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT00358618

Locations
Canada, British Columbia
British Columbia Children's Hospital, Anesthesia Dept.
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Simon Whyte The University of British Columbia
  More Information

No publications provided

Responsible Party: Dr. Simon Whyte, University of British Columbia
ClinicalTrials.gov Identifier: NCT00358618     History of Changes
Other Study ID Numbers: C06-0219, W06-0078
Study First Received: July 28, 2006
Last Updated: August 17, 2009
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Randomized
double-blind
3-group clinical interventional study

Additional relevant MeSH terms:
Propofol
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014