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Can a gentler anesthesia cocktail protect a child's developing brain?

NCT ID NCT03089905

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

The TREX trial tests whether a low-dose combination of sevoflurane, remifentanil, and dexmedetomidine leads to better long-term brain development than standard-dose sevoflurane in children under 2 who need anesthesia for at least 2 hours. Researchers will randomly assign 450 children to one of the two anesthesia approaches and assess their cognitive function at age 3 using IQ tests. The goal is to see if reducing exposure to certain anesthetic drugs can prevent potential neurodevelopmental problems.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A combination of low-dose sevoflurane, remifentanil, and dexmedetomidine
What this could lead to
If the low-dose combination works, it could give anesthesiologists a safer way to protect young children's brain development during long surgeries.
What could go wrong
This is a Phase 3 trial, but the long-term effects of anesthesia on the brain are still uncertain. The new combination may not improve outcomes, and it could have its own side effects like low blood pressure or slow heart rate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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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