Evaluating BriTurn Injection for Reversing Muscle Relaxation
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
Hanlim Pharm. Co., Ltd. · NCT06246331
This study is testing if BriTurn injection can safely reverse muscle relaxation in adults who have received certain anesthesia drugs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Hanlim Pharm. Co., Ltd. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06246331 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the clinical efficacy and safety of BriTurn injection or BrisTurn Prefilled injection in adult patients who have received Rocuronium or Vecuronium for neuromuscular blockade. The primary focus is on measuring the time it takes for the Train-Of-Four (TOF) ratio to reach 0.9, indicating effective reversal of muscle relaxation. Additionally, the study monitors safety outcomes, including the incidence of bradycardia, cardiac arrest, and bronchospasm. The study aims to provide valuable data on the effectiveness and safety profile of these injections in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years of age who have been administered BriTurn Injection or BrisTurn Prefilled Injection for neuromuscular blockade reversal.
Not a fit: Patients who are pregnant, nursing, or have contraindications to the injections will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of neuromuscular blockade reversal, leading to safer and more effective patient outcomes.
How similar studies have performed: While this study focuses on specific injections, similar approaches in reversing neuromuscular blockade have shown promise in previous research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Inje University Sanggye Paik Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Sangseok Lee — Inje University
- Study coordinator: Sangseok Lee
- Email: s2248@paik.ac.kr
- Phone: +82-2-950-1989
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Reversal of Neuromuscular Blockade