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

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

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)

Trial Locations (6)

3052

Royal Children's Hospital, Parkville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

75390

The University of Texas Southwestern Medical Center, Dallas

77030

Texas Children's Hospital, Houston

97239

Oregon Health and Science University, Portland

229899

KK Women's and Children's Hospital, Singapore

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

collaborator

Boston Children's Hospital

OTHER

collaborator

Oregon Health and Science University

OTHER

collaborator

Royal Children's Hospital

OTHER

collaborator

UMC Utrecht

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Sydney Children's Hospitals Network

OTHER

collaborator

The Cleveland Clinic

OTHER

collaborator

Princess Margaret Hospital for Children

OTHER

collaborator

University Hospital, Geneva

OTHER

collaborator

Starship Children's Health

UNKNOWN

collaborator

University of Texas Southwestern Medical Center

OTHER

collaborator

Gaslini Children's Hospital

OTHER

collaborator

KK Women's and Children's Hospital

OTHER_GOV

lead

Murdoch Childrens Research Institute

OTHER