Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
17/07/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr PD Booker

ORCID ID

Contact details

Department of Anaesthesia
Royal Liverpool Children's Hospital NHS Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 228 4811 x 2220

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes