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
Protocol serial number	2008/PAEDAN/01
Sponsor	University of Glasgow (UK)
Funder	Cardinal Health (USA)

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

Primary study design	Interventional
Study design	Interventional, single-arm, single-centre trial
Secondary study design	Single-centre
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	To be submitted to West Ethics Committee (Glasgow) in September 2008.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Propofol
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	3 Years
Sex	All
Target sample size at registration	50
Key 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
Key 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
Date of first enrolment	01/11/2008
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Department of Anaesthesia

Glasgow
G3 8SJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes