Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0013145919
Study information
Scientific title
Acronym
Study hypothesis
Sevoflurane and isoflurane are commonly used to anaesthetise patients with congenital heart disease. Which agent causes the least depression of cardiac function?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Condition
Heart disease
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Cardiac output, aortic and pulmonary blood flow, arterial pressure, systemic vascular resistance.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2003
Overall trial end date
01/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Subjects will be children with congenital cardiac abnormalities who are undergoing magnetic resonance imaging to achieve an accurate diagnosis and determine future treatment options.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Patient or parental refusal
2. Allergic, anaphylactic or other reactions to inhalational anaesthetic agents
3. Patients older than 16 years of age.
Recruitment start date
01/09/2003
Recruitment end date
01/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Theatres
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Guy's and St. Thomas' NHS Foundation Trust (UK) Own account, NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2008 results on http://www.ncbi.nlm.nih.gov/pubmed/18346608
Publication citations
-
Results
Dalal PG, Corner A, Chin C, Wood C, Razavi R, Comparison of the cardiovascular effects of isoflurane and sevoflurane as measured by magnetic resonance imaging in children with congenital heart disease., J Clin Anesth, 2008, 20, 1, 40-44, doi: 10.1016/j.jclinane.2007.08.004.