Investigating the impact of body composition on the activity of propofol in babies, infants and children undergoing anaesthesia.

Not Applicable

Recruiting

• Conditions: Anaesthesia; Obesity; Diet and Nutrition - Obesity; Anaesthesiology - Anaesthetics

• Registration Number: ACTRN12621000150842
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Last Update Posted: 12 September 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Participants will include 50 neonates infants and children aged 0-15 years undergoing surgical procedures at Starship Children’s Hospital. This study will include both obese and non-obese children. Obesity will be determined based on a BMI > 95% for age and sex, determined by the Children’s BMI calculator and assigned to one of 3 categories as defined as the % above the 95th centile, as follows:
•Obesity Grade I: > 95%-120% of 95th percentile (adult BMI >30 -35 equivalent)
•Obesity Grade II: 120-140% of 95th percentile (adult BMI 35- 40 equivalent)
•Obesity Grade III: > 140% of 95th percentile (adult BMI > 40 equivalent)

Exclusion Criteria

Children undergoing cardiac or liver transplant surgery will not be included.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify the influence of fat mass on propofol pharmacokinetics (assessed using clearance, volume of distribution and equilibration half-time) in neonates infants and children. [Blood samples will be collected at non-critical time points during the surgical procedure. Non-linear mixed effects models allow for flexible sampling times. We will try to obtain samples around 3, 6, 12 and 30 minutes after the propofol infusion commences. Additional samples will be taken at 15-30 minute intervals during the maintenance of anaesthesia. We will try to obtain our final sample 15-60 minutes after the propofol infusion is stopped. <br>];Fat mass assessed by dual X-ray absorptiometry[Modelling of these data will take place one the samples are collected and the plasma propofol concentrations have been measured. This will depend on the time taken by the analytical laboratory. ]

Secondary Outcome Measures

Name	Time	Method
Body composition determined by a composite of bioimpedance analysis and skin fold calliper measurements of the biceps, triceps, subscapular and suprailiac areas[This outcome will be assessed following completion of data collection. ]