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
Scientific
Department of Anaesthesia
Royal Hospital for Sick Children
Glasgow
G3 8SJ
United Kingdom
Study information
| Study design | Interventional, single-arm, single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/11/2008 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 3 Years |
| Sex | Both |
| Target number of participants | 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
- Scotland
- United Kingdom
Study participating centre
Department of Anaesthesia
Glasgow
G3 8SJ
United Kingdom
G3 8SJ
United Kingdom
Sponsor information
University of Glasgow (UK)
University/education
University/education
c/o Dr Melissa McBride
Research & Development Academic Coordinator
University Avenue
Glasgow
G12 8QQ
Scotland
United Kingdom
| melissa.mcbride@ggc.scot.nhs.uk | |
| Website | http://www.gla.ac.uk |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
