Condition category
Surgery
Date applied
16/08/2008
Date assigned
29/08/2008
Last edited
21/11/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Morton

ORCID ID

Contact details

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

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 measures

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

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

http://www.gla.ac.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes