The Trial Remifentanil DEXmedetomidine (TREX) trial

Full description

This dataset contains individual level perioperative data collected for the short term outcomes analysis of the multicentre TREX phase III randomised controlled trial. Infants less than 2 years of age undergoing general anaesthesia expected to last at least 2 hours were randomised 1:1 to low dose sevoflurane plus dexmedetomidine and remifentanil (LD SEVO) or standard dose sevoflurane (STD SEVO). Data cover intraoperative haemodynamics, anaesthetic events, recovery metrics, pain scores, and morbidity and mortality through postoperative day 5. The dataset enables comparison of the safety and feasibility profiles of LD SEVO vs STD SEVO techniques in early childhood. Prior to releasing any data the following are required: a data access agreement must be signed between relevant parties, the TREX Trial Steering Committee must see and approve the analysis plan describing how the data will be analysed, there must be an agreement around appropriate acknowledgement and any additional costs involved must be covered. Data will only be shared with a recognised research institution which has approved the proposed analysis plan. IPD Sharing Supporting Information Type Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code DOI: 10.1097/ALN.0000000000005232

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HeSANDA 1.0.0