NCT03728543

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

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Nowadays muscle relaxants are widely used in pediatric practice, but their use is fraught with numerous risks and complications. The main ones are the residual neuromuscular block and the possibility of developing a recurrence in the patient. In connection with this, the development and introduction into practical anesthesiology of new, more effective drugs for arresting the action of muscle relaxants is still relevant. One of the them, sugammadex was recently introduced into clinical practice and provided a fundamentally new approach to the recovery of neuromuscular conduction. Often, children under two years of 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 .

Conditions

• Anesthesia
• Pediatric Cancer
• Pediatric Tumor
• Pediatric Hepatoblastoma
• Beta-Thalassemia
• Hepatic Metastases

Interventions

Type	Name	Description
DRUG	Sugammadex	Introductory anesthesia: sevoflurane up to 8 rev /% + Air + O2 or propofol 1% 2 mg / kg intravenously. Maintenance: sevoflurane up to 3 rev /% + Air + O2, introduction of rocuronium bromide in a dose of 0.4 mg / kg, intravenously, as a bolus injection. At the end of anesthesia: sugammadex in a dose of 2 mg / kg, intravenously, as a bolus injection

Timeline

• Start date: 2018-11-15
• Primary completion: 2019-11-15
• Completion: 2019-11-20
• First posted: 2018-11-02
• Last updated: 2018-11-02

Locations

1 site across 1 country: Russia