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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03728543
• Other study ID #: NCPHOI-2018-04
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: November 15, 2018
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2018
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Contact: Marina Tikhonova, MD
• Phone: +79031985204
• Email: dr.tihonova[@]list.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: November 20, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery time of neuromuscular conduction	The time of the elimination of neuromuscular blockade (in seconds)	2 minutes post dose
Secondary	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
Secondary	Long-term toxicity	Assessment of all adverse events during next 24 hours	24 hours post-dose