Reversal of Neuromuscular BlockadeNCT06246331
Evaluation of the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection
An observational study of Reversal of Neuromuscular Blockade, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Reversal of Neuromuscular Blockade
- How many people
- 1,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jul 2023to 31 Dec 2024
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 19 years or older
Who may be able to join
- Adults over 19 years of age
- Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium
Who cannot join
- Pregnant women or nursing women
- Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inje University Sanggye Paik Hospital
Seoul, 01757
Sangseok Lee, +82-2-950-1989, s2248@paik.ac.kr
About this study
Official title: An Observational Study on the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection Administered for Reversal of Neuromuscular Blockade in Patients Receiving General Anesthesia
This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.
Read the detailed description
This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.
- Efficacy: Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
- Safety: whether bradycardia and resulting cardiac arrest occur or whether bronchospasm occurs
- Conditions
- Reversal of Neuromuscular Blockade
What is being measured
The primary outcome is the main question the study is designed to answer.
Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%) after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes
Measured: after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start21 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversal of Neuromuscular BlockadeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sangseok Lee, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246331
- Sponsor's protocol ID
- HL-BRT-401
- Status last verified
- Feb 2024
- First submitted
- 20 Dec 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection Administered for Reversal of Neuromuscular Blockade in Patients Receiving General Anesthesia
- ClinicalTrials.gov ID
- NCT06246331
- Acronym / sponsor ID
- HL-BRT-401
- Conditions
- Reversal of Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Feb 2024 (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.
This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.
Detailed description
This study evaluate clinical efficacy and safety in adult patients administered BriTurn injection or BrisTurn Prefilled injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium.
- Efficacy: Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
- Safety: whether bradycardia and resulting cardiac arrest occur or whether bronchospasm occurs
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 19 years or older
Key inclusion criteria (2 listed)
- Adults over 19 years of age
- Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium
Key exclusion criteria (2 listed)
- Pregnant women or nursing women
- Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%)
Time frame: after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes
Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%) after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Sangseok Lee principal investigator
Inje University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reversal of Neuromuscular Blockade, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
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 2 inclusion and 2 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 7 Feb 2024. 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 South Korea. 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.
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 Sangseok Lee (+82-2-950-1989, s2248@paik.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (minutes) for Train-Of-Four (TOF) ratio to reach 0.9 (90%) (time frame: after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes). 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 7 Feb 2024.