A Study to Compare the Long-term Outcomes After Two Different Anaesthetics (NCT03089905)
Neurodevelopmental Outcome After Standard Dose Sevoflurane Versus Low-dose Sevoflurane/Dexmedetomidine/Remifentanil Anaesthesia in Young Children- The TREX Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Boston Children's Hospital — Boston, Massachusetts
Age range: Not specified to 2 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (21 Sites)
- Boston Children's Hospital — Boston, Massachusetts
- Cleveland Clinic — Cleveland, Ohio
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- The University of Texas Southwestern Medical Center — Dallas, Texas
- Texas Children's Hospital — Houston, Texas
- Sydney Children's Hospital — Randwick, New South Wales
- Children's Hospital at Westmead — Westmead, New South Wales
- Queensland Children's Hospital — Brisbane, Queensland
- Women's and Children's Hospital — Adelaide, South Australia
- Flinders Medical Centre — Bedford Park, South Australia
- Royal Children's Hospital — Parkville, Victoria
- Perth Children's Hospital — Perth, Western Australia
- Presidio Ospedale Infantile C.Arrigo Azienda Ospedaliera — Alessandria,
- Azienda ospedaliero-universitaria di Bologna — Bologna,
- Azienda Ospedaliero-Universitaria Meyer — Florence,
- Istituto Giannina Gaslini — Genova,
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - Clinica Mangiagalli — Milan,
- Vittore Buzzi Children's Hospital — Milan,
- Azienda Ospedaliero Universitaria Pisana — Pisa,
- Ospedale Bambino Gesù — Roma,
- La Paz University Hospital — Madrid,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.