Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2008/PAEDAN/01
Study information
Scientific title
Acronym
Study hypothesis
The "Paedfusor" model performs within recognised acceptable limits of accuracy when used in children in the age group of 6 months to 3 years.
Ethics approval
To be submitted to West Ethics Committee (Glasgow) in September 2008.
Study design
Interventional, single-arm, single-centre trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Intravenous general anaesthesia in infants and young children
Intervention
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
Glasgow, G3 8YZ
United Kingdom
http://www.nhsgg.org.uk
Intervention type
Drug
Phase
Not Specified
Drug names
Propofol
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/11/2008
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Age <6 months or >3 years (>36 months)
2. Weight <7 kg or >=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
Recruitment start date
01/11/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Glasgow
G3 8SJ
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
c/o Dr Melissa McBride
Research & Development Academic Coordinator
University Avenue
Glasgow
G12 8QQ
United Kingdom
melissa.mcbride@ggc.scot.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Cardinal Health (USA)
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
Basic results (scientific)
Publication list