Clinical trial · Interventional
the Efficacy and Safety of Sugammadex in Children 0-2 Years Old
Efficacy and Safety Study of Sugammadex in Children 0-2 Years Old
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia | — | UNRESOLVED | — |
| Beta-Thalassemia | — | UNRESOLVED | — |
| Hepatic Metastases | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
| Pediatric Hepatoblastoma | Hepatoblastoma | ALIAS | 0.90 |
| Pediatric Tumor | Childhood Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sugammadex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Children 0-2yo
- description
- Children 0-2 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV
- interventionNames
- Drug: Sugammadex
- type
- ACTIVE_COMPARATOR
- label
- Children 2-18yo
- description
- Children 2-18 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV
- interventionNames
- Drug: Sugammadex
Primary outcomes (1)
- measure
- Recovery time of neuromuscular conduction
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available