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

Reversal of Neuromuscular Blockade Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246331
• Other study ID #: HL-BRT-401
• Status: Recruiting
• Start date: July 21, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Hanlim Pharm. Co., Ltd.
• Contact: Sangseok Lee
• Phone: +82-2-950-1989
• Email: s2248[@]paik.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Reversal of Neuromuscular Blockade

Locations

Country	Name	City	State
Korea, Republic of	Inje University Sanggye Paik Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	after administration of BriTurn Injection or BrisTurn Prefilled Injection up to 3 minutes