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 |
| Protocol serial number | N0013145919 |
| Sponsor | Department of Health |
| Funder | Guy's and St. Thomas' NHS Foundation Trust (UK) Own account, NHS R&D Support Funding |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 15/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Priti Dalal
Scientific
Scientific
Theatres
2nd Floor, New Guy House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Cardiac output, aortic and pulmonary blood flow, arterial pressure, systemic vascular resistance. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Theatres
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2008 | Yes | No |
