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

Hanlim Pharm

Status: Enrolling

Conditions: Reversal of Neuromuscular Blockade

Study type: Observational

Funder types: Industry

Identifiers

NCT06246331

HL-BRT-401

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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