Study to evaluate the optimal dose of remifentanil infusion(effective dose in 80% of patients) required to ensure apnoea (of 30 seconds duration) during magnetic resonance imaging of the heart under general anaesthesia in children aged 1 to 6 years.
- Conditions
- Study refers to the use of this medicine during anaesthesia given during the investigation of congenital heart disease.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2014-004346-10-GB
- Lead Sponsor
- Alder Hey Children's NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•Children 1 to 6 years of age (from first birthday to eve on seventh birthday).
•Scheduled for cardiac MR imaging under general anaesthesia at Alder Hey Children’s Hospital.
•Parental Consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•Hypersensitivity to any study drug
•Known abnormal response to opiate analgesics or co-morbidity associated with abnormal central control of breathing (such as obstructive sleep apnoea)
•Families unable to understand or complete consent
•Any other contraindication to proposed anaesthetic technique: at the discretion of the responsible anaesthetist.
•Documented significant renal or hepatic dysfunction
• Severe neurological disability
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method