T-REX trial

The T-REX trial aims to determine if low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia is associated with superior neurodevelopmental outcome, compared to standard-dose sevoflurane anaesthesia, in children less than two years of age, having anaesthesia expected to last two hours or longer.

Principal investigator: Professor Andrew Davidson at the University of Melbourne, Royal Children's Hospital and Murdoch Children's Research Institute.

The trial has completed enrolment of 450 patients at sites in Australia, the US and Italy. The T-REX trial team is pleased to report the following:

There were seven actively recruiting sites in Australia: Royal Children’s Hospital Melbourne; Queensland Children’s Hospital; Sydney Children’s Hospital; Perth Children’s Hospital and The Children’s Hospital at Westmead, Flinders Medical Centre and the Women’s and Children’s Hospital in Adelaide.
There were eight active sites in Italy and five sites in the US.

Study design
Phase III randomised active controlled, parallel group, assessor blinded, multicentre, superiority trial.

Primary outcome
Global cognitive function as assessed by the full scale IQ score of the Wechsler Preschool and Primary School Intelligence Scale assessed at three years of age.

Study population
Infants aged less than 2 years of age scheduled for surgery expected to last two hours or longer.

Sample size
450 patients.

The Australian National Health and Medical Research Council.
2022 IARS SmartTots Research Award (US)

ClinicalTrials.gov Identifier: NCT03089905

$A1000

For further information about this study, please contact the T-REX Project Manager, Suzette Sheppard by email.

Szmuk P, Andropoulos D, McGowan F, Brambrink A, Lee C, Lee KJ, McCann ME, Liu Y, Saynhalath R, Bong CL, Anderson BJ, Berde C, De Graaff JC, Disma N, Kurth D, Loepke A, Orser B, Sessler DI, Skowno JJ, von Ungern-Sternberg BS, Vutskits L, Davidson A. An open label pilot study of a dexmedetomidine-remifentanil-caudal anesthetic for infant lower abdominal/lower extremity surgery: The T REX pilot study. Paediatr Anaesth. 2019 Jan;29(1):59-67. doi: 10.1111/pan.13544.