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

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ClinicalTrials.gov Identifier: NCT03728543
Recruitment Status : Unknown
Verified November 2018 by Federal Research Institute of Pediatric Hematology, Oncology and Immunology.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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

Condition or disease Intervention/treatment Phase
Anesthesia Pediatric Cancer Pediatric Tumor Pediatric Hepatoblastoma Beta-Thalassemia Hepatic Metastases Drug: Sugammadex Phase 2 Phase 3

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Sugammadex in Children 0-2 Years Old
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : November 20, 2019


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 Name: 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 Name: Bridion




Primary Outcome Measures :
  1. Recovery time of neuromuscular conduction [ Time Frame: 2 minutes post dose ]
    The time of the elimination of neuromuscular blockade (in seconds)


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 90 minutes after the injection ]
    Assessment of all adverse events from the time of injection to the time of leaving of the MRI department

  2. Long-term toxicity [ Time Frame: 24 hours post-dose ]
    Assessment of all adverse events during next 24 hours



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728543


Contacts
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Contact: Marina Tikhonova, MD +79031985204 dr.tihonova@list.ru
Contact: Eugene Pashanov, Prof. PhD e.pashanov@gmail.com

Locations
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Russian Federation
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, Russian Federation
Sponsors and Collaborators
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Investigators
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Principal Investigator: Anna Konstantinova, MD Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
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Responsible Party: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
ClinicalTrials.gov Identifier: NCT03728543    
Other Study ID Numbers: NCPHOI-2018-04
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Federal Research Institute of Pediatric Hematology, Oncology and Immunology:
Anesthesia
Pediatrics
Pediatric oncology
MRI anesthesia
Additional relevant MeSH terms:
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Hepatoblastoma
Neoplasms
Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type