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NCT02353182 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Surgical Procedures, Operative, sponsored by Murdoch Childrens Research Institute.

Completed
Registry status
Phase 4
Development phase
60
Enrollment target
6
Study locations

NCT02353182: Completed Phase 4 study of Surgical Procedures, Operative, sponsored by Murdoch Childrens Research Institute.

NCT02353182 is a Phase 4 study of Surgical Procedures, Operative that has completed, run by Murdoch Childrens Research Institute. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02353182, a Phase 4 study of Surgical Procedures, Operative, has completed, sponsored by Murdoch Childrens Research Institute.

COMPLETED
Registry status
Phase 4
Development phase
60 participants
Enrollment target
6
Study locations

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.

Primary Outcome

Rescue treatment for light anaesthesia will be given if hypertension MAP \> 80 mmHg (confirmed with repeated measure) and/or patient movement.

Conditions Studied

Surgical Procedures, Operative

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
Murdoch Childrens Research Institute

4 total trials

What the finished NCT02353182 record still lists

NCT02353182 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).

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.

NCT02353182 lists 6 locations in 5 states (Texas, Ohio, Oregon).

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.

What interventions are being tested in trial NCT02353182?

The interventions under investigation include: Bupivacaine (DRUG), Dexmedetomidine (DRUG), Ropivacaine (DRUG), Remifentanil (DRUG).

Who is sponsoring clinical trial NCT02353182?

This trial is sponsored by Murdoch Childrens Research Institute, which has 4 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

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Where NCT02353182's enrollment target sits among peer trials

60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02353182, the US trial registry maintained by the National Library of Medicine. NCT02353182 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.