Evaluation of propofol target-controlled infusion (TCI) anaesthesia in infants aged 6 months to 3 years

ISRCTN ISRCTN00098907
DOI https://doi.org/10.1186/ISRCTN00098907
Secondary identifying numbers 2008/PAEDAN/01
Submission date
16/08/2008
Registration date
29/08/2008
Last edited
21/11/2012
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 Neil Morton
Scientific

Department of Anaesthesia
Royal Hospital for Sick Children
Glasgow
G3 8SJ
United Kingdom

Study information

Study designInterventional, single-arm, single-centre trial
Primary study designInterventional
Secondary study designSingle-centre
Study setting(s)Hospital
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesThe "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(s)To be submitted to West Ethics Committee (Glasgow) in September 2008.
Health condition(s) or problem(s) studiedIntravenous general anaesthesia in infants and young children
InterventionPropofol 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Propofol
Primary outcome measurePerformance 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 measuresPopulation 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 study start date01/11/2008
Completion date31/12/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit3 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2008
Date of final enrolment31/12/2009

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Department of Anaesthesia
Glasgow
G3 8SJ
United Kingdom

Sponsor information

University of Glasgow (UK)
University/education

c/o Dr Melissa McBride
Research & Development Academic Coordinator
University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom

Email melissa.mcbride@ggc.scot.nhs.uk
Website http://www.gla.ac.uk
ROR logo "ROR" https://ror.org/00vtgdb53

Funders

Funder type

Industry

Cardinal Health (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan