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

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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.

Study Overview

Start Date
July 21, 2023
Completion Date
December 31, 2024
Enrollment
1500
Date Posted
February 7, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Inje University Sanggye Paik Hospital
Seoul 01757, Korea, Republic of

Eligibility

Study Population
Adults aged 19 years or older
Minimum Age (years)
19
Eligibility Criteria
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 Contact Info

Study Contact Name
Sangseok Lee
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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
NCTid (if applicable)
NCT06246331