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Evaluation of the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06246331
Enrollment
1500
Registered
2024-02-07
Start date
2023-07-21
Completion date
2024-12-31
Last updated
2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reversal of Neuromuscular Blockade

Brief 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.

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

Interventions

None listed

Sponsors

Hanlim Pharm. Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults over 19 years of age * Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium

Exclusion criteria

* Pregnant women or nursing women * Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection

Design outcomes

Primary

MeasureTime frameDescription
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 minutesTime (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

Countries

South Korea

Contacts

Primary ContactSangseok Lee
s2248@paik.ac.kr+82-2-950-1989

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026