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NCT03089905 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Long-term Outcomes After Two Different Anaesthetics
A Phase 3 study of Anesthesia and Child Development, sponsored by Murdoch Childrens Research Institute.
- Active
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT03089905 is a Phase 3 study of Anesthesia and Child Development that is active but no longer recruiting, run by Murdoch Childrens Research Institute. The registered enrollment target is 450 participants, below the 109,402-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT03089905, a Phase 3 study of Anesthesia and Child Development, is active but no longer recruiting, sponsored by Murdoch Childrens Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study 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 wil
Conditions Studied
Interventions
- DRUG Dexmedetomidine
- DRUG Sevoflurane
- DRUG Remifentanil
Study Locations (20)
Other
- 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
Texas
- The University of Texas Southwestern Medical Center - Dallas
- Texas Children's Hospital - Houston
New South Wales
- Sydney Children's Hospital - Randwick
- Children's Hospital at Westmead - Westmead
South Australia
- Women's and Children's Hospital - Adelaide
- Flinders Medical Centre - Bedford Park
Massachusetts
- Boston Children's Hospital - Boston
Ohio
- Cleveland Clinic - Cleveland
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Queensland
- Queensland Children's Hospital - Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2017-08-10 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03089905
The ClinicalTrials.gov registry entry for NCT03089905 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109,402-participant average among 57 other Anesthesia trials with a reported enrollment target (100% lower). The listed sponsor is Murdoch Childrens Research Institute, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Anesthesia appearing as the primary indexed condition, and to 3 interventions - of which Dexmedetomidine is the first listed.
NCT03089905 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Texas, New South Wales.
Frequently Asked Questions
What is clinical trial NCT03089905 about?
NCT03089905 is a clinical study titled "A Study to Compare the Long-term Outcomes After Two Different Anaesthetics". 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 ...
What is the current status of trial NCT03089905?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2017-08-10. Estimated completion is 2026-06.
What conditions does trial NCT03089905 study?
This clinical trial studies the following conditions: Anesthesia, Child Development, Neurotoxicity.
What interventions are being tested in trial NCT03089905?
The interventions under investigation include: Dexmedetomidine (DRUG), Sevoflurane (DRUG), Remifentanil (DRUG).
Who is sponsoring clinical trial NCT03089905?
This trial is sponsored by Murdoch Childrens Research Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03089905 being conducted?
This trial has 20 study locations across Massachusetts, Ohio, Pennsylvania, Texas, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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