AnesthesiaPhase 2/3NCT03728543
the Efficacy and Safety of Sugammadex in Children 0-2 Years Old
A Phase 2/3 study testing Sugammadex in people with Anesthesia and Pediatric Cancer, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anesthesia, Pediatric Cancer, Pediatric Tumor
- What is being tested?
- Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteRussia
- Study dates
- 15 Nov 2018to 20 Nov 2019
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Eugene Pashanov, Prof. PhD contact
Russia1 site
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow
About this study
Official title: 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
Read the 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 .
- Conditions
- Anesthesia, Pediatric Cancer, Pediatric Tumor, Pediatric Hepatoblastoma, Beta-Thalassemia, Hepatic Metastases
- Being tested
- Sugammadex
- Keywords
- Anesthesia, Pediatrics, Pediatric oncology, MRI anesthesia
- Medical subject headings
- Neoplasms, Hepatoblastoma, beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time of neuromuscular conduction
The time of the elimination of neuromuscular blockade (in seconds)
Measured: 2 minutes post dose
Secondary outcomes (2)
Toxicity
Assessment of all adverse events from the time of injection to the time of leaving of the MRI department
Measured: 90 minutes after the injection
Long-term toxicity
Assessment of all adverse events during next 24 hours
Measured: 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start15 Nov 2018 (estimated)
- Primary completion15 Nov 2019 (estimated)
- Study completion20 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Konstantinova, MD, Principal investigator, Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728543
- Sponsor's protocol ID
- NCPHOI-2018-04
- Status last verified
- Nov 2018
- First submitted
- 25 Jun 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Sugammadex in Children 0-2 Years Old
- ClinicalTrials.gov ID
- NCT03728543
- Acronym / sponsor ID
- NCPHOI-2018-04
- Conditions
- Anesthesia, Pediatric Cancer, Pediatric Tumor, Pediatric Hepatoblastoma, Beta-Thalassemia, Hepatic Metastases
- Keywords
- Anesthesia, Pediatrics, Pediatric oncology, MRI anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 15 Nov 2018 (estimated)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 20 Nov 2019 (estimated)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Children 0-2yo | Experimental | Drug: SugammadexChildren 0-2 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV |
| Children 2-18yo | Active comparator | Drug: SugammadexChildren 2-18 years old with oncological diseases who need an MRI under general anesthesia, will receive sugammadex 2mg/kg IV |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- kidney failure
- liver failure
- critical conditions
- septicemia
- severe and decompensated diseases of the cardiovascular system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: BridionIntroductory 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 | Drug | Children 0-2yo, Children 2-18yo |
Primary outcome
Recovery time of neuromuscular conduction
Time frame: 2 minutes post dose
The time of the elimination of neuromuscular blockade (in seconds)
2 secondary outcomes
Toxicity
Time frame: 90 minutes after the injection
Long-term toxicity
Time frame: 24 hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eugene Pashanov, Prof. PhD contact
Anna Konstantinova, MD principal investigator
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sugammadex in people with Anesthesia and Pediatric Cancer, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Tikhonova, MD (+79031985204, dr.tihonova@list.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery time of neuromuscular conduction (time frame: 2 minutes post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.