Perioperative stress response in infants undergoing cardiac surgery: a comparison of three alfentanil dosage regimens

ISRCTN ISRCTN70255514
DOI https://doi.org/10.1186/ISRCTN70255514
Secondary identifying numbers N0206102381
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
17/07/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr PD Booker
Scientific

Department of Anaesthesia
Royal Liverpool Children's Hospital NHS Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom

Phone +44 (0)151 228 4811 x 2220

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesWhat is the smallest dose of alfentanil that minimises neuro-hormonal stress response in infants undergoing cardiac surgery?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Stress
InterventionPatients 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 typeProcedure/Surgery
Primary outcome measurePlasma cortisol concentration 5 min following sternotomy.
Secondary outcome measuresNot provided at time of registration
Overall study start date30/01/2004
Completion date30/03/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants90
Key inclusion criteria90 infants aged less than 1 year undergoing palliative or corrective surgery of congenital cardiac defects involving cardiopulmonary bypass.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment30/01/2004
Date of final enrolment30/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthesia
Liverpool
L12 2AP
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Charity

Royal Liverpool Children's NHS Trust (NHS R&D Support Funding)

No information available

Heartbeat

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan