The Effects of the Anesthetic Drug Propofol on the Way the Heart Recovers Between Beats
The Effects of Three Effect-site-targeted Propofol Concentrations on Dispersion of Myocardial Repolarization in Children
2 other identifiers
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 1, 2006
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedAugust 18, 2009
August 1, 2009
11 months
July 28, 2006
August 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Tpeak-end interval before & after intervention & between groups.
Secondary Outcomes (1)
Change in QT intervals before & after intervention & between groups.
Interventions
See Detailed Description.
Eligibility Criteria
You may qualify if:
- Health children (ASA I-II) undergoing procedures that require general anesthesia without pre-medication.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
British Columbia Children's Hospital, Anesthesia Dept.
Vancouver, British Columbia, V6H 3V4, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Whyte
The University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 28, 2006
First Posted
August 1, 2006
Study Start
September 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
August 18, 2009
Record last verified: 2009-08