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

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.

Conditions

• Surgical Procedures, Operative

Interventions

DRUG

Dexmedetomidine

Loading dose:1 mcg/kg over 10 minutes. Infusion: Start 1-1.5 mcg/kg/hr. Titrate up or down within 50% of starting doses as needed.

DRUG

Remifentanil

Loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2-0.5 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed.

DRUG

Bupivacaine

Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)

DRUG

Ropivacaine

Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• Boston Children's Hospital

  collaborator OTHER

• Oregon Health and Science University

  collaborator OTHER

• Royal Children's Hospital

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Sydney Children's Hospitals Network

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Princess Margaret Hospital for Children

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Starship Children's Health

  collaborator UNKNOWN

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Gaslini Children's Hospital

  collaborator OTHER

• KK Women's and Children's Hospital

  collaborator OTHER_GOV

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Andrew J Davidson, MD · Murdoch Childrens Research Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Month

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2016-09-30

Completion

2016-09-30

Countries

• United States
• Australia
• Singapore

Study Locations