Clinical trial NCT03728543: the Efficacy and Safety of Sugammadex in Children 0-2 Years Old
Official title: Efficacy and Safety Study of Sugammadex in Children 0-2 Years Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Anesthesia
Pediatric Cancer
Pediatric Tumor
Pediatric Hepatoblastoma
Beta-Thalassemia
Hepatic Metastases
Keywords: Anesthesia
Pediatrics
Pediatric oncology
MRI anesthesia
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 62
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief 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 .

Eligibility 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.

Primary outcomes:
measure: Recovery time of neuromuscular conduction
timeFrame: 2 minutes post dose
Secondary outcomes:
measure: Toxicity
timeFrame: 90 minutes after the injection
measure: Long-term toxicity
timeFrame: 24 hours post-dose
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Study officials:
affiliation: Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
name: Anna Konstantinova, MD
role: PRINCIPAL_INVESTIGATOR
References: