A Study to Compare the Long-term Outcomes After Two Different Anaesthetics
NCT ID: NCT03089905
Last Updated: 2025-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
450 participants
INTERVENTIONAL
2017-08-10
2026-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sevoflurane/dexmedetomidine/remifentanil
Dexmedetomidine: loading dose of 1mcg/kg over 10 minutes followed by an infusion of at 1 mcg/kg/hr.
Remifentanil: loading dose 1 mcg/kg over 2 minutes followed by an infusion starting at 0.1 mcg/kg/min or greater.
Sevoflurane: end tidal concentration of 0.6 -0.8% or less.
Sevoflurane
Experimental arm: end tidal concentration of 0.6 -0.8% or less. Active comparator arm: end tidal concentration of 2.5-3.0% or greater.
Remifentanil
Experimental arm: loading dose: 1 mcg/kg, infusion starting at 0.1 mcg/kg/min or greater.
Dexmedetomidine
Experimental arm: loading dose:1mcg/kg, infusion: 1 mcg/kg/hr.
Sevoflurane
End tidal concentration of 2.5-3.0% or greater.
Sevoflurane
Experimental arm: end tidal concentration of 0.6 -0.8% or less. Active comparator arm: end tidal concentration of 2.5-3.0% or greater.
Interventions
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Sevoflurane
Experimental arm: end tidal concentration of 0.6 -0.8% or less. Active comparator arm: end tidal concentration of 2.5-3.0% or greater.
Remifentanil
Experimental arm: loading dose: 1 mcg/kg, infusion starting at 0.1 mcg/kg/min or greater.
Dexmedetomidine
Experimental arm: loading dose:1mcg/kg, infusion: 1 mcg/kg/hr.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
ALL
No
Sponsors
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Sydney Children's Hospitals Network
OTHER
Baylor College of Medicine
OTHER
Boston Children's Hospital
OTHER
The Cleveland Clinic
OTHER
University of Texas, Southwestern Medical Center at Dallas
OTHER
Royal Children's Hospital
OTHER
Children's Hospital of Philadelphia
OTHER
Queensland Children's Hospital
OTHER_GOV
Perth Children's Hospital
UNKNOWN
Women and Children's Hospital
UNKNOWN
Istituto Giannina Gaslini
OTHER
Flinders Medical Centre
OTHER_GOV
Murdoch Childrens Research Institute
OTHER
Responsible Party
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Principal Investigators
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Andrew J Davidson, MD
Role: STUDY_CHAIR
Royal Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Sydney Children's Hospital
Randwick, New South Wales, Australia
Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
Brisbane, Queensland, Australia
Women's and Children's Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Royal Children's Hospital
Parkville, Victoria, Australia
Perth Children's Hospital
Perth, Western Australia, Australia
Presidio Ospedale Infantile C.Arrigo Azienda Ospedaliera
Alessandria, , Italy
Azienda ospedaliero-universitaria di Bologna
Bologna, , Italy
Azienda Ospedaliero-Universitaria Meyer
Florence, , Italy
Istituto Giannina Gaslini
Genova, , Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico - Clinica Mangiagalli
Milan, , Italy
Vittore Buzzi Children's Hospital
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, , Italy
Ospedale Bambino Gesù
Roma, , Italy
La Paz University Hospital
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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2024-512385-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
TREX TRIAL
Identifier Type: -
Identifier Source: org_study_id
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