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

February 4, 2024 updated by: Hanlim Pharm. Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 01757
        • Recruiting
        • Inje University Sanggye Paik Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults aged 19 years or older

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanlim Pharm. Co., Ltd.

Investigators

  • Principal Investigator: Sangseok Lee, Inje University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

February 4, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • HL-BRT-401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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