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Neurodevelopmental outcome after standard dose sevoflurane versus low-dose Sevoflurane/Dexmedetomidine/Remifentanil anaesthesia in young children- the TREX trial

NCT ID NCT03089905

NEW Sponsor: Murdoch Childrens Research Institute Source: ClinicalTrials.gov ↗

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Ongoing This study
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The trial has finished. Results may not be published yet.
Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Approved
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First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

There is considerable evidence that most general anaesthetics modulate brain development in animal studies. The impact is greater with longer durations of exposure and in younger animals. There is great controversy over whether or not these animal data are relevant to human clinical scenarios. The changes seen in preclinical studies are greatest with GABA agonists and NMDA antagonists such as volatile anaesthetics (eg sevoflurane), propofol, midazolam, ketamine, and nitrous oxide. There is less evidence for an effect with opioid (such as remifentanil) or with alpha 2 agonists (such as dexmedetomidine). Some, but not all, human cohort studies show an association between exposure to anaesthesia in infancy or early childhood and later changes in cognitive tests, school performance or risk of developing neurodevelopmental disorders. The evidence is weak due to possible confounding. A recent well designed cohort study (the PANDA study) comparing young children that had hernia repair to their siblings found no evidence for a difference in a range of detailed neuropsychological tests. In that study most children were exposed to up to two hours of anaesthesia. The only trial (the GAS trial) has compared children having hernia repair under regional or general anesthesia and has found no evidence for a difference in neurodevelopment when tested at two years of age. The GAS and PANDA studies confirm the animal data that short exposure is unlikely to cause any neurodevelopmental impact. The impact of longer exposures is still unknown. In humans the strongest evidence for an association between surgery and poor neurodevelopmental outcome is in infants having major surgery. However, this is also the group where confounding is most likely. The aim of our study is to see if a new combination of anaesthetic drugs results in a better long-term developmental outcome than the current standard of care for children having anaesthesia expected to last 2 hours or longer. Children will be randomised to receive either a low dose sevoflurane/remifentanil/dexmedetomidine or standard dose sevoflurane anaesthetic. They will receive a neurodevelopmental assessment at 3 years of age to assess global cognitive function.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

450 people

The number who actually took part.

Started

Aug 2017

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 2 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Younger than 2 years (chronological age) * Scheduled for anaesthesia that is expected to last at least 2 hours (and/or total operating room time is scheduled to be at least 2.5 hours) * Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Exclusion Criteria: * Known neurologic, chromosomal or congenital anomaly which is likely to be associated with poor neurobehavioural outcome * Existing diagnosis of behavioural or neurodevelopmental disability * Prematurity (defined as \< 36 weeks gestational age at birth) * Birth weight less than 2 kg. * Congenital cardiac disease requiring surgery * Intracranial neurosurgery and intracranial craniofacial surgery (isolated cleft lip is not an exclusion) * Previous cumulative exposure to general anaesthesia exceeding 2 hours * Planned future cumulative exposure to anaesthesia exceeding 2 hours before the age of 3 years. * Any specific contra-indication to any aspect of the protocol * Previous adverse reaction to any anaesthetic * Circumstances likely to make long term follow-up impossible * Living in a household where the primary language spoken at home is not a language in which we can administer the Wechsler Preschool and Primary School Intelligence Scale * Planned postoperative sedation with any agent except opioids (e.g. benzodiazepines, dexmedetomidine, ketamine, barbiturates, propofol, clonidine, chloral hydrate, and other non-opioid sedatives). For example if such sedation is planned for post-operative ventilation

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Conditions

The condition(s) this trial relates to.

toxic encephalopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anesthesia Child development Neurotoxicity

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Italy

  • Azienda Ospedaliero-Universitaria Meyer

    Florence, Italy

  • Azienda ospedaliero-universitaria di Bologna

    Bologna, Italy

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145, Australia

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - Clinica Mangiagalli

    Milan, Italy

  • Istituto Giannina Gaslini

    Genova, Italy

  • La Paz University Hospital

    Madrid, Spain

  • Ospedale Bambino Gesù

    Roma, Italy

  • Perth Children's Hospital

    Perth, Western Australia, 6008, Australia

  • Presidio Ospedale Infantile C.Arrigo Azienda Ospedaliera

    Alessandria, Italy

  • Queensland Children's Hospital

    Brisbane, Queensland, 4101, Australia

  • Royal Children's Hospital

    Parkville, Victoria, 3052, Australia

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031, Australia

  • Texas Children's Hospital

    Houston, Texas, 77030, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Vittore Buzzi Children's Hospital

    Milan, Italy

  • Women's and Children's Hospital

    Adelaide, South Australia, 5006, Australia

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