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ISRCTN
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ISRCTN81324728
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ClinicalTrials.gov identifier
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Public title
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A comparison of the effects of Sevoflurane and Isoflurane on cardiovascular parameters measured by cardiac magnetic resonance imaging in paediatric patients with congenital heart disease. A randomised controlled trial.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0013145919
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Study hypothesis
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Sevoflurane and isoflurane are commonly used to anaesthetise patients with congenital heart disease. Which agent causes the least depression of cardiac function?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Heart disease
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Participants - inclusion criteria
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Subjects will be children with congenital cardiac abnormalities who are undergoing magnetic resonance imaging to achieve an accurate diagnosis and determine future treatment options.
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Participants - exclusion criteria
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1. Patient or parental refusal
2. Allergic, anaphylactic or other reactions to inhalational anaesthetic agents
3. Patients older than 16 years of age.
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Anticipated start date
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01/09/2003
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Anticipated end date
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01/09/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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10
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Interventions
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The routine study usually lasts 1 hour. For the first 30 minutes, each subject will be anaesthetised with one of the agents. The agent will then be swapped and the patients anaesthetised with the other agent for the remaining 30 minutes. Variables will be recorded at the end of each period.
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Primary outcome measure(s)
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Cardiac output, aortic and pulmonary blood flow, arterial pressure, systemic vascular resistance.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Guy's and St. Thomas' NHS Foundation Trust (UK) Own account, NHS R&D Support Funding
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Trial website
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Publications
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2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18346608
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Contact name
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Dr
Priti
Dalal
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Address
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Theatres
2nd Floor, New Guy House
Guy's Hospital
St Thomas' Street
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City/town
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London
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Zip/Postcode
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SE1 9RT
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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15/07/2009
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Date ISRCTN assigned
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30/09/2005
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