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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000693022

Enrollment

Registered

2010-08-20

Start date

2010-11-25

Completion date

2012-06-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

1 Years to 16 Years

Healthy volunteers

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

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.

Outcome results