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

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

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

Study Overview

• Status: Unknown
• Conditions: Anesthesia; Pediatric Cancer; Beta-Thalassemia; Hepatic Metastases; Pediatric Tumor; Pediatric Hepatoblastoma
• Intervention / Treatment: Drug: Sugammadex

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Marina Tikhonova, MD; Phone Number: +79031985204; Email: dr.tihonova@list.ru
• Study Contact Backup: Name: Eugene Pashanov, Prof. PhD; Email: e.pashanov@gmail.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children 0-2yo; Children 0-2 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV	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; Other Names: Bridion
Active Comparator: Children 2-18yo; Children 2-18 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV	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; Other Names: Bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery time of neuromuscular conduction	The time of the elimination of neuromuscular blockade (in seconds)	2 minutes post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity	Assessment of all adverse events from the time of injection to the time of leaving of the MRI department	90 minutes after the injection
Long-term toxicity	Assessment of all adverse events during next 24 hours	24 hours post-dose

Collaborators and Investigators

• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Investigators: Principal Investigator: Anna Konstantinova, MD, Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Study record dates

Study Major Dates

• Study Start (Anticipated): November 15, 2018
• Primary Completion (Anticipated): November 15, 2019
• Study Completion (Anticipated): November 20, 2019

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Pediatrics; Anesthesia; Pediatric oncology; MRI anesthesia
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Neoplasms, Complex and Mixed; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Neoplasms; Thalassemia; beta-Thalassemia; Hepatoblastoma
• Other Study ID Numbers: NCPHOI-2018-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
• IPD Sharing Time Frame: Data will be available within 6 month of study completionData
• IPD Sharing Access Criteria: data access requests will be reviewed by the chief investigator and the local administration
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No