biostudies-literatureUnknownDisma NAgenzia Italiana del Farmaco, Ministero della Salute<h4>Introduction</h4>Dexmedetomidine is the sedative agent administered in combination with remifentanil and low dose of sevoflurane in the interventional arm of the ongoing TREX trial (Trial Remifentanil DExmedetomidine). The TREX pilot study (published in Paediatr Anaesth 2019;29:59-67) established infusion rates higher than those initially proposed. This could be attributed to an inappropriate target concentration for sedation or incorrect initial pharmacokinetic parameter estimates.<h4>Methods</h4>The TREX study is a Phase III, randomized, active controlled, parallel group, blinded evaluator, multicentre, superiority trial comparing neurological outcome after standard sevoflurane anaesthesia with dexmedetomidine/remifentanil and low dose sevoflurane anaesthesia in children aged less thPaediatric anaesthesiahttps://www.ebi.ac.uk/biostudies/studies/S-EPMC10107467biostudies-literatureJustification Of Empiric Methodology to Determine Dexmedetomidine Dose for the TREX Study.PMC10107467AIFA‐TRS‐2018‐00001250Morse JDBocca PPatrone EDe Lorenzo BIengo ACordani RCaramelli FDi Persio ABlesi LCairoli SCalderini EPicardo SPasini LMontagnini LNeri SRobino CPistone BBonfiglio RCirillo GTucci ITREX (Trial Remifentanil DEXmedetomidine) Italian InvestigatorsLenares EDisma NKuppers BIzzo FGoffredo BMGarrone MColantonio LDiotto VAnderson BJfalseJustification Of Empiric Methodology to Determine Dexmedetomidine Dose for the TREX Study.<h4>Introduction</h4>Dexmedetomidine is the sedative agent administered in combination with remifentanil and low dose of sevoflurane in the interventional arm of the ongoing TREX trial (Trial Remifentanil DExmedetomidine). The TREX pilot study (published in Paediatr Anaesth 2019;29:59-67) established infusion rates higher than those initially proposed. This could be attributed to an inappropriate target concentration for sedation or incorrect initial pharmacokinetic parameter estimates.<h4>Methods</h4>The TREX study is a Phase III, randomized, active controlled, parallel group, blinded evaluator, multicentre, superiority trial comparing neurological outcome after standard sevoflurane anaesthesia with dexmedetomidine/remifentanil and low dose sevoflurane anaesthesia in children aged less th2022-01-01T00:00:00Z2022 Nov2026-07-14T20:16:17.126Z2024-11-09T21:04:00.973ZS-EPMC101074673639842310.1111/pan.14605