Childhood obesity and propofol infusio

Phase 4

• Conditions: Childhood obesity; Anaesthesiology - Other anaesthesiology; Diet and Nutrition - Obesity

• Registration Number: ACTRN12611000451909
• Lead Sponsor: Auckland City Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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[Sampling at 2, 5, 10 and 15 minutes and the 15 minutely until cessation of infusion.<br>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 Measures

Name	Time	Method
Bi spectral index vs arterial propofol concentration<br>Continuous BIS recording will be related to actual arterial concentration at the measured time points.<br>This will enable construction of a BIS response curve as well as estimation of the time to peak effect.[Continuous until cessation infusion]