Dettagli per singolo studio

DEC-NET Serial number GB325

Published online	18/10/2004 12.39.00
Last updated	01/08/2005 11.44.38

Other protocol ID number	00/44/RE
This trial has been approved by an ethics committee
Current trial status	Open (actively recruiting new participants)
First subject enrolment Target N. of subjects	06/2004 90
Major Disease (ICD9 class)	HRT DIS POSTCARDIAC SURG
Experimental drug
Alfentanil Treatment regimen (dosage and duration) 1) Loading dose 75 ug kg -1 given over 20 min after induction of anaesthesia, followed by an infusion of 1.5 ug kh -1 min -1 unitl exit from the theatre. 2) Loading dose 75 ug kg -1 given over 20 min after induction of anaesthesia followed by and infusion of 3 ug kg -1 min -1 until exit from the theatre. 3) Loading dose 100 ug kg -1 given over 20 min after induction of anaesthesia followed by an infusion of 6 ug kg-1 min-1 until exit from the theatre.
Gender	Both
Age (range)	< one year
Eligibility criteria
Inclusion criteria
infants undergoing cardiac surgery
Exclusion criteria
Patients receiving opioids or steroids preoperatively. Patients with abnormal hepatic or renal function. Patients who require inotropic drugs support preoperatively and patients requiring support preoperatively.
Trial design/methodology
Phase	4
Kind of study
Design	Controlled Randomised Blinded Double blind
Purpose of study
To establish the smallest dose of alfentanil that minimises neuro-hormonal stress response in infants undergoing cardiac surgery
Primary outcomes
Plama cortisol concentration 5 minutes following stermotomy
Secondary outcomes
Plasma glucose concentration 5 min after sternotomy
Summary of study design, objectives, and ongoing research findings
To establish the smallest dose of alfentanil that minimises neuro-hormonal stress response in infants undergoing cardiac surgery