CompletedPhase 3ACTRN12610000693022

A trial to compare the accuracy of two methods for delivering Propofol in children

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

Sponsor

Royal Children's Hospital

Enrollment

40 participants

Start Date

Nov 25, 2010

Study Type

Interventional

Conditions

Children having major surgery that necessitates use of an intra-arterial catheter and who are suitable for an intravenous (Propofol)-based anaesthetic.

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.

Eligibility

Sex: Both males and femalesMin Age: 1 YearsMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two methods of delivering an anaesthetic drug (Propofol) in children aged 1 to 16 having surgery. Your child must be having a procedure expected to last 1 to 8 hours and need an arterial line for monitoring. Children with severe organ problems, allergies to Propofol, or known heart shunts cannot participate.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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.

Locations(1)

Australia

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ACTRN12610000693022