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.

ISRCTN	ISRCTN81324728
DOI	https://doi.org/10.1186/ISRCTN81324728
Secondary identifying numbers	N0013145919

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Priti Dalal
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Scientific title
Study objectives	Sevoflurane and isoflurane are commonly used to anaesthetise patients with congenital heart disease. Which agent causes the least depression of cardiac function?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Cardiac output, aortic and pulmonary blood flow, arterial pressure, systemic vascular resistance.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2003
Completion date	01/09/2004

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	10
Key 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.
Key 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.
Date of first enrolment	01/09/2003
Date of final enrolment	01/09/2004

Theatres

London
SE1 9RT
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Hospital/treatment centre

Guy's and St. Thomas' NHS Foundation Trust (UK) Own account, NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2008		Yes	No