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

NCT03728543 | Unknown Phase 2

• 1 other identifier: NCPHOI-2018-04
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Anesthesia; Pediatrics; Pediatric oncology; MRI anesthesia

Outcome Measures

Primary Outcomes (1)

• Recovery time of neuromuscular conduction

  The time of the elimination of neuromuscular blockade (in seconds)

  2 minutes post dose

Secondary Outcomes (2)

• Toxicity

  90 minutes after the injection

• Long-term toxicity

  24 hours post-dose

Study Arms (2)

Children 0-2yo

EXPERIMENTAL

Children 0-2 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV

Drug: Sugammadex

Children 2-18yo

ACTIVE COMPARATOR

Children 2-18 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV

Drug: Sugammadex

Interventions

Sugammadex DRUG

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

Also known as: Bridion

Children 0-2yo; Children 2-18yo

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal Research Institute of Pediatric Hematology, Oncology and Immunology: lead

Study Sites (1)

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Moscow, Russia

Location

MeSH Terms

Conditions

Neoplasms; Hepatoblastoma; beta-Thalassemia

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Anna Konstantinova, MD

  Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Tikhonova, MD

CONTACT

+79031985204; dr.tihonova@list.ru

Eugene Pashanov, Prof. PhD

CONTACT

e.pashanov@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: November 2, 2018
• Study Start: November 15, 2018
• Primary Completion: November 15, 2019
• Study Completion: November 20, 2019
• Last Updated: November 2, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 month of study completionData
• Access Criteria: data access requests will be reviewed by the chief investigator and the local administration

Locations

RU (1)