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Trials / Unknown

UnknownNCT06246331

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

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

Status
Unknown
Phase
Study type
Observational
Enrollment
1,500 (estimated)
Sponsor
Hanlim Pharm. Co., Ltd. · Industry
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2023-07-21
Primary completion
2024-12-31
Completion
2024-12-31
First posted
2024-02-07
Last updated
2024-02-07

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06246331. Inclusion in this directory is not an endorsement.

Evaluation of the Clinical Efficacy and Safety of BriTurn Injection or BrisTurn Prefilled Injection (NCT06246331) · Clinical Trials Directory