Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000451909
Ethics application status
Not yet submitted
Date submitted
2/05/2011
Date registered
3/05/2011
Date last updated
3/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Childhood obesity and propofol infusion
Scientific title
The pharmacokinetics and pharmacodynamics of propofol infusion in obese children.
Secondary ID [1] 260091 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 265767 0
Condition category
Condition code
Anaesthesiology 265917 265917 0 0
Other anaesthesiology
Diet and Nutrition 265928 265928 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacokinetic study involving propofol infusion and arterial blood sampling
Target controlled infusion of propofol utilisng the Kataria pharmacokinetic dataset and titrating target plasma concentration to achieve a bispectral index between 40 and 60.
There will be both obese (50) and non-obese (10) groups.
Intervention code [1] 264505 0
Treatment: Drugs
Comparator / control treatment
Non-obese children
Control group
Active

Outcomes
Primary outcome [1] 266677 0
Arterial blood concentration of propofol vs time with subsequent pharmacokinetic analysis utilisng mixed effect modelling to assess the impact of obesity on propofol infusion pharmacokinetics
Timepoint [1] 266677 0
Sampling at 2, 5, 10 and 15 minutes and the 15 minutely until cessation of infusion.
Sampling will then occur at 2, 5, 10, 15 minutes and then 15 minutely following cessation until removal of the arterial sampling line.
Secondary outcome [1] 276178 0
Bi spectral index vs arterial propofol concentration
Continuous BIS recording will be related to actual arterial concentration at the measured time points.
This will enable construction of a BIS response curve as well as estimation of the time to peak effect.
Timepoint [1] 276178 0
Continuous until cessation infusion

Eligibility
Key inclusion criteria
Children 5 - 15 years old
Obese defined as by the age and sex corrected BMI figures of Cole
Surgical or investigative procedure requiring general anaesthetic
Control group will include ten 5-15 year old normal range BMI patients recieving general anaestehtic
Minimum age
5 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiopulmonary bypass and liver transplantation.
Propofol or propofol emulsion component allergy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3440 0
New Zealand
State/province [1] 3440 0

Funding & Sponsors
Funding source category [1] 264997 0
Charities/Societies/Foundations
Name [1] 264997 0
A+ charitable trust
Country [1] 264997 0
New Zealand
Funding source category [2] 265003 0
Charities/Societies/Foundations
Name [2] 265003 0
Society for paediatic anaesthesia in Australia and New Zealand
Country [2] 265003 0
Australia
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Private Bag 92 024
Auckland Mail Centre
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 264088 0
None
Name [1] 264088 0
Address [1] 264088 0
Country [1] 264088 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266950 0
Northern X regional committee
Ethics committee address [1] 266950 0
Private Bag 92-522
Wellesley St
Auckland 1141
Ethics committee country [1] 266950 0
New Zealand
Date submitted for ethics approval [1] 266950 0
14/06/2011
Approval date [1] 266950 0
Ethics approval number [1] 266950 0

Summary
Brief summary
A pharmacokinetic and pharmacodynamic study aiming to investigate the impact of childhood obesity on propofol infusion. General anaesthesia will be carried out with propofol infusion (Using Kataria PK model). Arterial blood sampling will determine pharmacokinetics and BIS monitoring will determine pharmacodynamics. Pharmacokinetic analysis will focus on how best to account for obesity in children recieving propofol infusion.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 32558 0
Address 32558 0
Country 32558 0
Phone 32558 0
Fax 32558 0
Email 32558 0
Contact person for public queries
Name 15805 0
James Houghton
Address 15805 0
Department of Anaesthesia
Starship Children's Hospital
Private Bag 92 024
Auckland Mail Centre
Auckland 1142
Country 15805 0
New Zealand
Phone 15805 0
+6493670000
Fax 15805 0
Email 15805 0
[email protected]
Contact person for scientific queries
Name 6733 0
James Houghton
Address 6733 0
Department of Anaesthesia
Starship Children's Hospital
Private Bag 92 024
Auckland Mail Centre
Auckland 1142
Country 6733 0
New Zealand
Phone 6733 0
+6493670000
Fax 6733 0
Email 6733 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.