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

NCT ID: NCT06246331

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-21

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Reversal of Neuromuscular Blockade

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sangseok Lee

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

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Inje University Sanggye Paik Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sangseok Lee

Role: CONTACT

+82-2-950-1989

Facility Contacts

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Sangseok Lee

Role: primary

+82-2-950-1989

Other Identifiers

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HL-BRT-401

Identifier Type: -

Identifier Source: org_study_id

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