EPI-VOX feasibility trial
Research type
Research Study
Full title
The EPIgenetic consequences in children of Volatile-based anaesthesia and surgery, with high or low OXygen exposure (EPI - VOX) – A single centre, double-blinded, randomised, feasibility trial
IRAS ID
1006664
Contact name
Joseph Larvin
Contact email
Sponsor organisation
University Hospital Southampton National Health Service (NHS) Foundation Trust
ISRCTN Number
ISRCTN58025172
Research summary
More than half a million children have an anaesthetic each year in the UK. Though anaesthesia in these children is usually thought to be safe, concerns remain about potential long-term health effects of the drugs used. During general anaesthesia children also require additional oxygen, but there remains uncertainty over the safest amount of oxygen to give. Evidence suggests that both too much and too little oxygen could cause harm.
Gene expression is the process by which instructions in DNA are used to make products such as proteins. Laboratory studies have shown that anaesthetic drugs and oxygen may both alter gene expression through a process called epigenetics.
This study will focus on children aged under 3 undergoing general anaesthesia for hip surgery at University Hospital Southampton and will run for up to 12 months. Participants will be given either 25% or 60% oxygen (chosen at random) during their operation – both values within the normal amounts of oxygen that may be used during anaesthesia. A small blood sample (between 1 and 2 teaspoons) will be collected at the start and end of their first anaesthetic and then again at the start of their second anaesthetic when their cast is changed. Blood samples will only be taken when the child is under anaesthetic. The samples from the different times will be analysed to look for any changes in signals on DNA (epigenetic changes) and other markers which may be associated with the anaesthetic drugs, and results from the two different oxygen levels will be compared.
There is relatively less medical research carried out in children and this work will show whether this type of study is possible in this age-group and provide information for future trials. It will help towards improving our understanding of the effects of anaesthesia ultimately help doctors and families make better informed decisions.REC name
London - Central Research Ethics Committee
REC reference
22/LO/0881
Date of REC Opinion
19 May 2023
REC opinion
Further Information Favourable Opinion