Perioperative stress response in infants undergoing cardiac surgery: a comparison of three alfentanil dosage regimens
| ISRCTN | ISRCTN70255514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70255514 |
| Protocol serial number | N0206102381 |
| Sponsor | Department of Health (UK) |
| Funders | Royal Liverpool Children's NHS Trust (NHS R&D Support Funding), Heartbeat |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | What 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) studied | 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 |
| Primary outcome measure(s) |
Plasma cortisol concentration 5 min following sternotomy. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 90 |
| Key inclusion criteria | 90 infants aged less than 1 year undergoing palliative or corrective surgery of congenital cardiac defects involving cardiopulmonary bypass. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 30/01/2004 |
| Date of final enrolment | 30/03/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthesia
Liverpool
L12 2AP
United Kingdom
L12 2AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
