The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.
Completed · Phase 4
Conditions studied: Surgical Procedures, Operative
In brief
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.
Key facts
- Study ID
- NCT02353182
- Run by
- Murdoch Childrens Research Institute
- People needed
- 60
- Starts
- 2015-05-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2016-10-26
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants aged 1 to 12 months (corrected age)
- ASA I or II
- Infants undergoing lower abdominal/lower extremity surgery anticipated to be > 120 minutes in duration
- Surgery requires caudal regional nerve block
You may not qualify if…
- ASA III or higher
- Any contraindication to caudal analgesia
- Any contraindication to an inhalational induction with sevoflurane
- Allergies to any medication in study protocol
- Planned admission to an ICU postoperatively (except level II or III neonatal ICU)
- Planned tracheal intubation postoperatively
- Mechanical ventilation postoperatively
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Oregon Health and Science University — Portland, Oregon, United States
- The University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Texas Children's Hospital — Houston, Texas, United States
- Royal Children's Hospital — Parkville, Victoria, Australia
- KK Women's and Children's Hospital — Singapore, Singapore
Full record on ClinicalTrials.gov
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