drugset
drugset / Trial / NCT02353182

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

NCT02353182 ↗

Phase 4 Completed 60 enrolled Murdoch Childrens Research Institute Baylor College of Medicine · collabBoston Children's Hospital · collabChildren's Hospital Medical Center, Cincinnati · collabChildren's Hospital of Philadelphia · collabGaslini Children's Hospital · collabKK Women's and Children's Hospital · collabOregon Health and Science University · collabPrincess Margaret Hospital for Children · collabRoyal Children's Hospital · collabStarship Children's Health · collabSydney Children's Hospitals Network · collabThe Cleveland Clinic · collabUMC Utrecht · collabUniversity Hospital, Geneva · collabUniversity of Texas Southwestern Medical Center · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-05
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.175 % Other
Subject Bupivacaine Other / unclassified 0.25 % Other
Subject Dexmedetomidine Other / unclassified 1 ug/kg Intravenous
Subject Dexmedetomidine Other / unclassified 1.5 ug/kg Intravenous
Subject Remifentanil Small molecule 0.2 ug/kg Intravenous
Subject Remifentanil Small molecule 0.5 ug/kg Intravenous
Subject Ropivacaine Other / unclassified 0.2 % Other

Indications

No indication recorded.