Evaluation of the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection
- Conditions
- Reversal of Neuromuscular Blockade
- Registration Number
- NCT06246331
- Lead Sponsor
- Hanlim Pharm. Co., Ltd.
- Brief 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.
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- Adults over 19 years of age
- Subject administered BriTurn Injection or BrisTurn Prefilled Injection for reversal of neuromuscular blockade induced by Rocuronium or Vecuronium
- Pregnant women or nursing women
- Subject to prohibition according to the permission of BriTurn Injection or BrisTurn Prefilled Injection
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Inje University Sanggye Paik Hospital
🇰🇷Seoul, Korea, Republic of