New Clinical Trial for Efficacy and Safety of Sugammadex in 0-2 Years Old Children

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Federal Research Institute of Pediatric Hematology, Oncology and Immunology is about to launch a clinical study at Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology in Moscow (Russian Federation). Bridion® is currently not recommended for infants less than 2 years of age. Often, children in this age need general anesthesia for MRI (prolonged stay in the device, apnea to get a high-quality image without respiratory artifacts, severe pain syndrome, severe neurological deficit, etc.). The aim of the study is the evaluation of the efficacy of sugammadex, estimated by restoring neuromuscular conduction within 0-120 seconds after bolus administration, and the safety and tolerability of sugammadex in children under two years of age. Children will be observed in the hospital during 24 hours. A group of patients from 2 to 18 years of age, in whom the drug sugammadex is used as standard therapy will be taken as a comparison group.

Estimated Study Start Date : November 15, 2018

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