Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0206102381
Study information
Scientific title
Acronym
Study hypothesis
What is the smallest dose of alfentanil that minimises neuro-hormonal stress response in infants undergoing cardiac surgery?
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
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Stress
Intervention
Patients will be given one of three alfentanil dose regimens by random allocation. Serial blood sampling will be used to provide plasma for analysis of markers of neuro-hormonal response.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Plasma cortisol concentration 5 min following sternotomy.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/01/2004
Overall trial end date
30/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
90 infants aged less than 1 year undergoing palliative or corrective surgery of congenital cardiac defects involving cardiopulmonary bypass.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
90
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/01/2004
Recruitment end date
30/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Liverpool
L12 2AP
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Royal Liverpool Children's NHS Trust (NHS R&D Support Funding)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Heartbeat
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