Children undergoing general anaesthesia MedDRA version: 9.1 Level: LLT Classification code 10021722 Term: Induction and maintenance anaesthesia
Conditions
Interventions
Product Name: propofol 2%
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: PROPOFOL
CAS Number: 2078548
Concentration unit
Sponsors
NHS Greater Glasgow & Clyde and University of Glasgow
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female children aged 6m-3y (inclusive) Weight 7-16kg Elective surgery of expected duration > /=30 minutes ASA Grade 1 or 2 Written informed consent from parent Child suitable for intravenous induction and maintenance of anaesthesia with propofol Children with no contraindication to application of local anaesthetic cream or gel to the cannulation site for intravenous induction Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Age 3y (>36m) Weight /=17kg Children undergoing urgent or emergency surgical procedures Expected duration of surgery < 30 minutes ASA Grade 3-5 No written informed consent from parent Children with difficult venous access Children who need or wish inhalational induction Children who will need intermittent positive pressure ventilation along with the use of muscle relaxant Patients who need sedative premedication Propofol contraindicated (allergy to propofol or its formula components) Local anaesthetic cream or gel contraindicated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The “Paedfusor” model performs within recognised acceptable limits of accuracy when used in children in the age group of 6 months to 3 years.; Main Objective: Performance of the “Paedfusor” pharmacokinetic model for children age 6m-3y, weight 7-16kg as calculated from the 4 standard parameters described by Varvel et al. 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 – C pred)/Cpred] x 100 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. ;Secondary Objective: Population pharmacokinetics of propofol in children age 6m – 3y 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