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

Launched by UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST · Jun 29, 2023

Keywords

ClinConnect Summary

The EPIVA trial is studying how different types of anesthesia used during surgery might affect the genes of young children. Specifically, it looks at children under 3 years old who are having surgery for a condition called hypospadias, which affects the penis's normal development. The trial compares two common methods of anesthesia: one where the drugs are given through a small tube in a vein, and another where the drugs are inhaled as gas. Researchers will take a small blood sample from the children at the beginning and end of the surgery to check for any changes in gene activity that could happen as a result of the anesthesia.

To participate in this trial, children must be between 6 months and 3 years old and scheduled for hypospadias surgery that will take at least an hour. Parents or legal guardians need to provide consent for their child's participation. This important research aims to improve our understanding of how anesthesia might affect brain development in young children, helping doctors and families make better decisions about anesthesia in the future.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Age ≥6 months and ≤ 3 years at time of initial operation
• • Undergoing hypospadias surgery
• • Maintenance phase of anaesthesia for procedure has an estimated length of ≥1 hour (established through MDT discussion prior to surgery).
• • Completed informed consent form (ICF) from legal representative (LR (this is the person who is empowered to give informed consent on behalf of a participant. For most children this will be one or both parents. This may also be a guardian or custodian with legal custody)).
• Exclusion Criteria:
• • LR unable to provide completed ICF
• • Withdrawal of consent at any stage
• • Previous exposure to general anaesthesia at any stage of life, including in-utero (through maternal exposure at any stage until delivery)
• • Neurodevelopmental/neurodisability diagnosis (given or under investigation) from a paediatric service including autistic specturm disorder (ASD), attention deficit disorder (ADHD), traumatic brain injury (TBI), down's syndrome, cerebral palsy, epilepsy
• • Known contraindication to either volatile-based inhalational anaesthesia or TIVA (surgery or participant)
• • Clinician refusal