the Efficacy and Safety of Sugammadex in Children 0-2 Years Old

• Status: Unknown status
• Trial end date: 2019-11-20
• Target enrollment: 0
• Participant gender: All

Summary

Sugammadex is a selective antidote to muscle relaxants rocuronium bromide and vecuronium bromide. Sugammadex is a modified gamma-cyclodextrin, a compound that selectively binds rocuronium bromide and vecuronium bromide. It forms a complex with them in the blood plasma, which leads to the decrease in the concentration of muscle relaxant binding to nicotinic receptors in the neuromuscular synapse. The result is the the elimination of neuromuscular blockade caused by rocuronium bromide or vecuronium bromide. Sugammadex is used to eliminate neuromuscular blockade caused by rocuronium bromide in children aged 2 years and adolescents in standard clinical situations. The aim of the study is to prove the efficacy and safety of sugammadex in children under 2 years

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Treatments: Anesthetics

Criteria

Inclusion Criteria:

• Children 0 to 2 years (0 - 24 months, inclusive) in the study group; children from 2 to 18 years in the comparison group (control group)

• Patients with malignant neoplasms of the liver, malignant neoplasms with metastatic liver damage, beta-thalassemia

• Informed consent of the patient and / or parents or trustee of the patient

Exclusion Criteria:

• kidney failure

• liver failure

• critical conditions

• septicemia

• severe and decompensated diseases of the cardiovascular system

• refusal of the patient and / or his parents or trustee to participate in the study.