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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.

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. - Dose of remifentanil for cardiac scans under anaesthesia in children.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-004346-10-GB
Enrollment
Unknown
Registered
2015-02-18
Start date
2015-04-15
Completion date
Unknown
Last updated
2015-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Study refers to the use of this medicine during anaesthesia given during the investigation of congenital heart disease.

Interventions

Trade Name: Ultiva Product Name: Ultiva Pharmaceutical Form: Powder for injection INN or Proposed INN: remifentanil CAS Number: 132875-61-7 Concentration unit: mg milligram(s) Concentration type: equa

Sponsors

Alder Hey Children's NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

MeasureTime frame
Main Objective: What is the optimal maintenance dose of remifentanil, during breath hold episodes, in children (age 1 to 6 years) having magnetic resonance imaging of the heart under general anaesthesia. The optimal dose is defined as the dose required to inhibit breathing for at least 30 seconds in 80% of children.;Secondary Objective: What is the impact of remifentanil dose on the quality of magnetic resonance scans? What is the impact of remifentanil dose on heart rate (lowest heart rate during study period)? What is the impact of remifentanil dose on blood pressure (lowest blood pressure during study period)? Evidence of toxicity of remifentanil (specifically cardiovascular events requiring specific measures to treat);Primary end point(s): Movement of the diaphragm (detected by the MRI scanner) during a single test apnoea of 30 seconds duration.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026