The TREX Trial
There is considerable evidence in animals that prolonged exposure to many anaesthetic agents (such as sevoflurane) has an impact on the developing brain. There is some evidence that Alpha 2 agonists (such as dexmedetomidine) do not produce the same changes. There is human cohort data to suggest an association between surgery in early childhood and increased risk of poorer neurodevelopmental outcome. It is unknown if this association is due to anaesthetic toxicity or other confounding factors. The TREX Trial is a multisite RCT comparing neurodevelopmental outcome after sevoflurane versus dexmedetomidine/remifentanil anaesthesia in infants. Inclusion criteria include children up to two years of age having anaesthesia expected to last at least 2 hours. Exclusion criteria include known risk factors for poor neurobehavioural outcome. The primary outcome will be global cognitive function as assessed by the full scale IQ score of the WPPSI-IV assessed at 3 years of age.
Royal Children's Hospital Melbourne
Parts of research done:
Literature review, Research proposal, Ethics approval, Data collection
New study sites
NHMRC, ANZCA, MCRI