The Effects of the Anesthetic Drug Propofol on the Way the Heart Recovers Between Beats - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00358618

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

MedlinePlus related topics: Anesthesia

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	The Effects of Three Effect-Site-Targeted Propofol Concentrations on Dispersion of Myocardial Repolarization in Children

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:	July 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358618

Contacts

Contact: Joanne Lim

604-875-2000 ext 6669

jlim2@cw.bc.ca

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

Responsible Party:	University of British Columbia ( Dr. Simon Whyte )
Study ID Numbers:	C06-0219, W06-0078
Study First Received:	July 28, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00358618
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Randomized
double-blind
3-group clinical interventional study

Study placed in the following topic categories:

Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Physiological Effects of Drugs

Central Nervous System Depressants
Anesthetics
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009