Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
15/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Priti Dalal

ORCID ID

Contact details

Theatres
2nd Floor
New Guy House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes