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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 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. The trial reports 6 study locations across 5 states.

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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.

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

What the Registry Record Tells You About NCT02353182

The ClinicalTrials.gov registry entry for NCT02353182 describes a study currently listed as completed, categorized as Phase 4. 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 4 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 5 distinct geographic areas - top geographies include 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.

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

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