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Neurodevelopmental outcome after standard dose sevoflurane versus low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia in young children: The TREX Trial
Study ID: STU 052017-065
Summary
This is a Phase iii randomised active controlled, parallel group, assessor blinded, multicentre, superiority trial. 450 male or female children less than 2 years of age will be enrolled. There are two arms; the low-dose sevoflurane/dexmedetomidine/remifentanil arm and the standard dose sevoflurane arm. Randomisation 1:1 will be stratified by site and age at exposure (less than 12 months and greater than 12 months). Randomisation will be in blocks of variable size. The treating anaesthetist will not be blinded to treatment arm. The assessing neuropsychologist and parents will be blinded to treatment arm. neuropsychological tests will be conducted when the child is 3 years of age (chronological age) within a three month window either side of their birthday (WPPSi-iV, CeLF-P2, nePSY-2, Parent Questionnaires).
Participant Eligibility
* -Younger than 2 years (chronological age) * -Scheduled for surgery that is expected to last at least 2 hours (and/or total operating room time is scheduled to be at least 2.5 hours) * -Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant[Right Quote]s behalf.
- Cancer Related
- No
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- PETER SZMUK
UNIVERSITY OF TEXAS SOUTHWESTERN
Primary objective The primary objective of this trial is to determine if, in children less than 2 years of age having surgery expected to last 2.5 hours or longer, low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia is superior to standard dose sevoflurane anaesthesia in terms of the global cognitive function as assessed by the full scale iQ score of the Wechsler Preschool and Primary School intelligence Scale assessed at 3 years of age. Secondary objectives Secondary objectives include determining if, in children less than 2 years of age having surgery expected to last 2.5 hours or longer, low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia is superior to standard dose sevoflurane anaesthesia in terms of: a) a range of other neurodevelopmental tests performed at 3 years of age including subscales of general cognitive functioning, language, executive function, memory, adaptive behaviour, clinical behaviour and social skills. b) diagnosis of any neurodevelopment disorder at 3 years of age. Secondary outcomes also include determining if, in children less than 2 years of age having surgery expected to last 2.5 hours or longer, low-dose sevoflurane/dexmedetomidine/remifentanil anaesthesia is superior to standard dose sevoflurane anaesthesia in terms of: a) incidence of intra-operative hypotension, b) intra-operative bradycardia, c) post-operative pain, d) time to recovery.
