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

Inclusion Criteria3

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

Exclusion Criteria5

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.

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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