Childhood obesity and propofol infusion

The pharmacokinetics and pharmacodynamics of propofol infusion in obese children.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000451909

Enrollment

Registered

2011-05-03

Start date

2011-11-01

Completion date

Unknown

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

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.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

5 Years to 15 Years

Healthy volunteers

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

Exclusion criteria

Cardiopulmonary bypass and liver transplantation. Propofol or propofol emulsion component allergy

Outcome results