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COMPLETED Phase 4

The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.

NCT02353182 · View on ClinicalTrials.gov ↗

Study Summary

Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these findings are relevant to humans but the issue has become a major concern. Recent data have found that monkeys exposed to anaesthesia as infants grow up to have slower learning than those not exposed. The aim of the TREX pilot study is to determine the feasibility of an alternative anaesthetic regimen for lower abdominal/lower extremity surgery in infants 1-12 months of age.

Interventions

  • DRUG Bupivacaine
  • DRUG Dexmedetomidine
  • DRUG Ropivacaine
  • DRUG Remifentanil

Study Locations (6)

Texas

  • The University of Texas Southwestern Medical Center — Dallas
  • Texas Children's Hospital — Houston

Ohio

  • Cincinnati Children's Hospital Medical Center — Cincinnati

Oregon

  • Oregon Health and Science University — Portland

Victoria

  • Royal Children's Hospital — Parkville

Other

  • KK Women's and Children's Hospital — Singapore

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2015-05
Est. Completion 2016-09
Phase Phase 4

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02353182

The ClinicalTrials.gov registry entry for NCT02353182 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Murdoch Childrens Research Institute, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Surgical Procedures, Operative appearing as the primary indexed condition, and to 4 interventions — of which Bupivacaine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02353182 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Texas, Ohio, Oregon. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02353182 about?

NCT02353182 is a clinical study titled "The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.". Animal studies suggest general anaesthetics harm the developing brain. It is unclear if these findings are relevant to humans but the issue has become a major concern. Recent data have found that monkeys exposed to anaesthesia as infants grow up to have slower learning than those not exposed. The a...

What is the current status of trial NCT02353182?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2015-05. Estimated completion is 2016-09.

What conditions does trial NCT02353182 study?

This clinical trial studies the following conditions: Surgical Procedures, Operative. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02353182?

The interventions under investigation include: Bupivacaine (DRUG), Dexmedetomidine (DRUG), Ropivacaine (DRUG), Remifentanil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02353182?

This trial is sponsored by Murdoch Childrens Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02353182 being conducted?

This trial has 6 study locations across Ohio, Oregon, Texas, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial