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Trial registered on ANZCTR


Registration number
ACTRN12610000693022
Ethics application status
Approved
Date submitted
19/08/2010
Date registered
20/08/2010
Date last updated
27/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial to compare the accuracy of two methods for delivering Propofol in children
Scientific title
A randomised control trial comparing accuracy of two commercially available pharmacokinetic algorithms for total intravenous anaesthesia (TIVA) using Propofol in children aged 1-16 years
Secondary ID [1] 252513 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children having major surgery that necessitates use of an intra-arterial catheter and who are suitable for an intravenous (Propofol)-based anaesthetic. 258002 0
Condition category
Condition code
Anaesthesiology 258171 258171 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to receive a propofol intravenous anaesthetic which will be delivered by either the Kataria or Paedfusor algorithm. These algorithms will deliver the "predicted plasma levels" (Cp).
The intervention will occur only once: ie each participant will be only randomised once and will only have surgery once.
The dose amount given will differ on a case by case basis and propofol delivery will be calculated on target blood level, age and weight.
Intervention code [1] 257047 0
Treatment: Drugs
Comparator / control treatment
During anaesthesia, approximately 9 blood samples of 0.5ml are obtained from each participant. Samples will be from an intra-arterial catheter. These samples will deliver the "measured plasma levels" (Cm)
Control group
Active

Outcomes
Primary outcome [1] 259033 0
To determine the accuracy of pharmacokinetic algorithms in children. This will be performed by comparing measured arterial plasma concentrations of Propofol (cm) with concurrent predicted (cp) plasma levels.
Timepoint [1] 259033 0
Samples to be collected at 3 and 8 minutes post commencement of propofol infusion; 2 minutes after a reduction or increase in the target concentration; during stable anaesthesia (60 minutes between sample if long procedure); just prior to ceasing the Target Controlled Infusion (TCI) system; 3 and 8 minutes after cessation; and upon participant?s eye opening.
Secondary outcome [1] 265275 0
Bispectral index (BIS) measurements as a surrogate measure of Propofol concentration in the brain.
Timepoint [1] 265275 0
BIS measurements to be taken at same time as arterial measurements: at 3 and 8 minutes post commencement of propofol infusion; 2 minutes after a reduction or increase in the target concentration; during stable anaesthesia (60 minutes between sample if long procedure); just prior to ceasing the TCI system; 3 and 8 minutes after cessation; and upon participant?s eye opening.
Secondary outcome [2] 265276 0
Observation of perceived benefits of Propofol including a possible reduction in post-operative nausea and vomiting and airway problems.
Timepoint [2] 265276 0
Until participant is discharged from recovery.

Eligibility
Key inclusion criteria
Children aged 1-16 yrs old having surgery necessitating insertion of an arterial line for intra-operative monitoring
American Society of Anesthesiologists (ASA) status 1-3
Surgical procedure expected to last between 1-8 hours
Minimum age
1 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of severe impairment of respiratory, hepatic, renal or endocrine function
Allergy to any constituents of Propofol
Patients with known intra or extra-cardiac “shunts” (that allow mixing of arterial and venous blood, affecting measurements of Propofol)
Patients who are intended to receive Ketamine at doses greater than 0.4 mg/kg/hr (may interfere with BIS readings)
Treating anaesthetist excluding the patient if unfamiliar with the use of Propofol TCI for anaesthesia maintenance.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients aged 3-16 years of age will be randomised to either the Kataria or Paedfusor algorithm after parents and/or participants give informed consent to participate. Randomisation allocations will be delivered using sealed, opaque, sequentially numbered envelopes. Patients <3 years old will not be randomised, but will be allocated to the Paedfusor algorithm.
This is not a blinded study, ie: anaesthetists will not be blinded to the algorithm that the participants are randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients aged 3-16 years of age will be randomised to either the Kataria or Paedfusor algorithm in a 1:1 ratio with variable block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257494 0
Hospital
Name [1] 257494 0
Royal Children's Hospital
Address [1] 257494 0
Flemington Road
Parkville
Victoria 3052
Country [1] 257494 0
Australia
Primary sponsor type
Hospital
Name
Royal Children's Hospital
Address
Flemington Road
Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 256727 0
None
Name [1] 256727 0
Address [1] 256727 0
Country [1] 256727 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259521 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 259521 0
Flemington Road
Parkville
Victoria 3052
Ethics committee country [1] 259521 0
Australia
Date submitted for ethics approval [1] 259521 0
16/08/2010
Approval date [1] 259521 0
12/10/2010
Ethics approval number [1] 259521 0
30112

Summary
Brief summary
The aim of this project is to assess how accurately we can predict what the level of Propofol is in the blood. We will be assessing the accuracy of two paediatric pharmacokinetic algorithms (Paedfusor and Kataria) that are designed to deliver Propofol at a specific blood concentration. The two different programmes deliver the Propofol at different doses according to the target blood level, age and weight. We will do this by comparing measured arterial plasma concentrations of Propofol (cm) with concurrent predicted (cp) plasma levels.
Trial website
Trial related presentations / publications
* TIVA in paediatrics Dr Peter Squire ANZCA ASM 2011
Public notes

Contacts
Principal investigator
Name 31545 0
Dr Peter Squire
Address 31545 0
Department of Anaesthesia & Pain Management
Royal Children's Hospital
Flemington Road
Parkville VIC
3052
Country 31545 0
Australia
Phone 31545 0
+61393455233
Fax 31545 0
+61393456003
Email 31545 0
peter.squire@rch.org.au
Contact person for public queries
Name 14792 0
Ms Suzette Sheppard
Address 14792 0
Department of Anaesthesia and Pain Management
Royal Children's Hospital
Flemington Road
Parkville, Victoria 3052
Country 14792 0
Australia
Phone 14792 0
+61 3 9345 5233
Fax 14792 0
+61 3 9345 6003
Email 14792 0
suzette.sheppard@mcri.edu.au
Contact person for scientific queries
Name 5720 0
Dr Dr Peter Squire
Address 5720 0
Department of Anaesthesia and Pain Management
Royal Children's Hospital
Flemington Road
Parkville, Victoria 3052
Country 5720 0
Australia
Phone 5720 0
+61 3 9345 5233
Fax 5720 0
+61 3 9345 6003
Email 5720 0
peter.squire@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary