Intravenous general anaesthesia in infants and young children Surgery
Conditions
Interventions
Propofol 2% infusion anaesthesia delivered by TCI system using the "Paedfusor" software.
Details of Joint Sponsor:
NHS Greater Glasgow and Clyde
Dalian House
PO Box 15329
350 St. Vincent Street
Glasg
Sponsors
University of Glasgow (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male and female children aged 6 months - 3 years (inclusive) 2. Weight 7-16 kg 3. Elective surgery of expected duration >=30 minutes 4. American Society of Anaesthesiologists (ASA) Grade 1 or 2 5. Written informed consent from parent 6. Child suitable for intravenous induction and maintenance of anaesthesia with propofol 7. Children with no contraindication to application of local anaesthetic cream or gel to the cannulation site for intravenous induction
Exclusion criteria
Exclusion criteria: 1. Age 3 years (>36 months) 2. Weight =17 kg 3. Children undergoing urgent or emergency surgical procedures 4. Expected duration of surgery <30 minutes 5. ASA Grade 3-5 6. No written informed consent from parent 7. Children with difficult venous access 8. Children who need or wish inhalational induction 9. Children who will need intermittent positive pressure ventilation along with the use of muscle relaxant 10. Patients who need sedative premedication 11. Propofol contraindicated (allergy to propofol or its formula components) 12. Local anaesthetic cream or gel contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Performance of the "Paedfusor" pharmacokinetic model for children aged 6 months - 3 years, weight 7-16 kg as calculated from 4 standard parameters (see below). The performance error (PE) is calculated from the concentration of propofol measured in whole blood (Cmeas) and the concentration predicted by the software (Cpred) as follows: PE(%) = [(Cmeas ? Cpred)/Cpred] x 100 The four standard measures of performance are derived from this value, namely bias, precision, divergence and wobble. These derived parameters estimate whether the system over- or under-delivers propofol, by how much and how this varies between patients and for an individual patient over time. The blood propofol samples will be taken throughout surgery and one sample 4 hours afterwards. | — |
Secondary
| Measure | Time frame |
|---|---|
| Population pharmacokinetics of propofol in children aged 6 months - 3 years, calculated using non-linear effects modelling (NONMEM). This allows calculations of volume of distribution and clearance of propofol, and any relationships between these pharmacokinetic parameter values and patients age, gender and weight to be statistically evaluated. | — |
Countries
United Kingdom
Outcome results
None listed