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Alpha 2 Agonist

Anesthetics for Child Development Outcomes (TREX Trial)

Phase 3
Waitlist Available
Research Sponsored by Murdoch Childrens Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years of age
Awards & highlights

TREX Trial Summary

This trial will help determine 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.

Who is the study for?
This trial is for children under 2 years old who are scheduled for an anesthesia expected to last at least 2 hours. They must have a guardian to consent and cannot have been born prematurely, had certain surgeries, or be planned for postoperative sedation with non-opioid agents.Check my eligibility
What is being tested?
The study tests if a low dose combination of sevoflurane, remifentanil, and dexmedetomidine leads to better long-term cognitive outcomes compared to standard dose sevoflurane in young children requiring lengthy anesthesia.See study design
What are the potential side effects?
Possible side effects from the anaesthetics may include nausea, vomiting, drowsiness or agitation upon waking up. Rarely there might be more serious effects like allergic reactions or heart rate changes.

TREX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am under 2 years old.
Select...
My upcoming surgery is expected to last at least 2 hours under anesthesia.

TREX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Full Scale IQ
Secondary outcome measures
Adaptive behaviour
Attention/Executive Function/impulse control
Clinical Behavior
+8 more

TREX Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sevoflurane/dexmedetomidine/remifentanilExperimental Treatment3 Interventions
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.
Group II: SevofluraneActive Control1 Intervention
End tidal concentration of 2.5-3.0% or greater.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sevoflurane
2016
Completed Phase 4
~1260
Remifentanil
2019
Completed Phase 4
~1610
Dexmedetomidine
2015
Completed Phase 4
~1980

Find a Location

Who is running the clinical trial?

Royal Children's HospitalOTHER
33 Previous Clinical Trials
229,212 Total Patients Enrolled
Boston Children's HospitalOTHER
761 Previous Clinical Trials
5,579,280 Total Patients Enrolled
The Cleveland ClinicOTHER
1,026 Previous Clinical Trials
1,365,626 Total Patients Enrolled

Media Library

Dexmedetomidine (Alpha 2 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03089905 — Phase 3
Neurotoxicity Research Study Groups: Sevoflurane/dexmedetomidine/remifentanil, Sevoflurane
Neurotoxicity Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT03089905 — Phase 3
Dexmedetomidine (Alpha 2 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03089905 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What types of procedures often involve the use of Sevoflurane?

"While typically used as a sedative, sevoflurane has also been effectively used to treat general anesthesia, pain management, and other anesthesia procedures."

Answered by AI

What is the current enrollment for this research project?

"In order to properly conduct this clinical trial, 450 individuals who match the pre-determined inclusion criteria are needed to participate. There are many trial sites where patients can choose to participate, such as Cleveland Clinic in Cleveland, Ohio and The University of Texas Southwestern Medical Center in Dallas, Texas."

Answered by AI

How many research hospitals are managing this clinical trial?

"Currently, this clinical trial is being run at 5 sites, which are situated in cities such as Cleveland, Dallas and Houston. If you are considering participating in this trial, please select the site that is closest to your location to reduce travel-related commitments."

Answered by AI

What is the anesthetic Sevoflurane's efficacy in other surgical cases?

"Sevoflurane was first studied in 2005 at Università Vita-Salute San Raffaele in Milano, Italy. As of now, there have been 1050 completed studies. Out of the 170 clinical trials currently underway, many are based in Cleveland, Ohio."

Answered by AI

Does Sevoflurane have any short-term or long-term health risks?

"There is some evidence to support sevoflurane's efficacy, as well as data suggesting that it is a safe intervention. Our team has given it a score of 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Compare the Long-term Outcomes After Two Different Anaesthetics
2017. "A Study to Compare the Long-term Outcomes After Two Different Anaesthetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03089905.
~59 spots leftby Apr 2025
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