Active not recruitingNAINTERVENTIONAL

The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery (EPIVA)

This study, called EPIVA, is investigating how general anaesthesia affects very young children during surgery. Each year, thousands of children in the UK have general anaesthesia, and doctors want to understand if the medicines used have any long-term effects on their development. We're looking at how different ways of giving anaesthesia – either through a vein or as a gas – might change a child's genes. These changes are called 'epigenetics'. We'll take small blood samples from children aged 6 months to 3 years having a specific surgery (hypospadias repair) to see if these gene changes happen. The study aims to gather important information for future research and help families and doctors make the best choices about anaesthesia.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

Start

03 Aug 2023

Estimated completion

30 Sep 2026

Hypospadias Anesthesia; Adverse Effect Perioperative Complication Pediatric ALL

What is this study about?

When children need an operation, they are given general anaesthesia to make them sleep and stop them feeling pain. There are two main ways doctors keep someone asleep during surgery: either by giving medicines directly into a vein through a small tube, or by giving different medicines as a gas for them to breathe in. Both methods are very common and considered safe.

Doctors are always learning more about how these powerful medicines affect our bodies, especially in young children whose bodies are still developing. There's been some discussion about whether anaesthetic drugs might affect how a child's brain develops, and if there could be any long-term health effects. This study wants to explore this further, focusing on something called "epigenetics." This is about how the instructions in our DNA (our genes) are used to make different things our body needs. Anaesthetic drugs might change how these instructions are read, without actually changing the DNA itself, which is what epigenetics is all about.

To understand this better, this study will look at children aged between 6 months and 3 years old who are having surgery for a condition called hypospadias (a problem with the penis that needs fixing). These children will receive their anaesthesia in one of the two usual ways – either through a vein or as a gas. Small blood samples (about 1 to 2 teaspoons) will be taken when they are asleep, both at the start and end of their operation. Scientists will then look at these blood samples to see if there are any changes in the genetic signals after anaesthesia. This research is important because there isn't a lot of information about these effects in very young children, and it will help doctors and parents in the future make more informed decisions about anaesthesia.

Key takeaways

Study examines two common types of anaesthesia in young children.
Investigating 'epigenetic' changes – how anaesthesia might affect gene activity.
Involves children aged 6 months to 3 years having hypospadias surgery.
Small blood samples (1-2 teaspoons) taken during surgery while child is asleep.
Aims to improve understanding for future medical decisions by doctors and families.
Participation will not change your child's surgery or direct medical care.

Who may be eligible?

This study is looking for boys aged between 6 months and 3 years old. They need to be having a specific operation called hypospadias surgery, which is a planned procedure. The surgery itself needs to be expected to last at least an hour while the child is fully asleep.

Before your child can join, your local doctor or guardian will need to give their full permission by signing a consent form. This form explains everything about the study. If you're unable to provide this consent, your child won't be able to take part.

There are also some reasons why a child might not be able to join. For example, if they've had general anaesthesia before, even when they were in the womb if their mother had it. Children with certain existing conditions that affect their brain development, like autism or cerebral palsy, or those who have had severe head injuries, also can't participate. Lastly, if there's any medical reason your child can't have one of the two types of anaesthesia being studied, or if their doctor thinks it's not suitable, they won't be able to join.

Quick self-check

Is your child a boy aged between 6 months and 3 years?
Is your child scheduled for hypospadias surgery?
Is the surgery expected to last at least one hour under anaesthesia?
Has your child never had general anaesthesia before (including in the womb)?
Does your child NOT have any diagnosed conditions affecting brain development (like autism or cerebral palsy)?
Are you able to provide signed permission for your child to join the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in this study, they will have their general anaesthesia given in one of the two usual ways: either through a vein or as a gas. Which method is used will be decided randomly, like flipping a coin. During their regular surgery, two small blood samples will be collected while they are asleep – one at the very start of the operation and one just before it finishes. Each sample will be only about 1 to 2 teaspoons of blood. Apart from these blood samples, your child's care and recovery will be exactly the same as for any other child having this surgery. There are no extra visits or follow-up appointments directly linked to this study, and no additional medications are given. The total duration of your child's direct involvement is just limited to the time they are in surgery.

Potential risks and benefits

Taking part in this study might help us learn more about how different anaesthetics affect children, which could improve future care for many. While there's no direct medical benefit to your child from taking part, the information gathered is very valuable for future research. The main risk is the collection of two small blood samples, which carry the usual small risks associated with any blood test, such as minor bruising or slight discomfort at the time of collection. However, these will be taken while your child is already asleep for their surgery. You are free to withdraw your child from the study at any time without having to give a reason, and this will not affect their medical care.

Locations (1)

University Hospital Southampton
Southampton, United Kingdom

Common questions

What is 'general anaesthesia'?

General anaesthesia is when special medicines are used to make a child completely unconscious (asleep) during an operation so they won't feel any pain or remember the surgery.

What is 'epigenetics'?

Epigenetics is about small changes that can happen to our DNA (our genetic instruction book). These changes can affect how our body reads and uses those instructions, without actually changing the instructions themselves.

Will my child know they are in a study?

No, your child is too young to fully understand, and all study procedures like blood tests happen while they are asleep for their surgery. You, as their parent or guardian, will give permission.

Will taking part change my child's surgery?

No, your child will receive the same high standard of care and either of two common types of anaesthesia they would typically get for this surgery. The only difference is the collection of two tiny blood samples.

What happens to the blood samples?

The blood samples will be analysed by scientists to look for any epigenetic changes or other markers, which means looking at how your child's genes might be affected by the anaesthesia.