Analyzing the use and effects of sugammadex in patients after surgery
A Multicenter, Prospective, Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety in Non-interventional, Real-world Setting
This study looks at how sugammadex is used and its effects on patients who have surgery with general anesthesia and receive certain muscle relaxants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul, Seongbuk-gu) |
| Trial ID | NCT05788718 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the prescription patterns, effectiveness, and safety of sugammadex in patients undergoing elective surgery with general anesthesia, specifically those receiving rocuronium or vecuronium as neuromuscular blocking agents. Data will be collected from patients who are observed from baseline until 24 hours after sugammadex administration, without any additional tests or interventions. The study aims to provide insights into real-world usage and outcomes associated with sugammadex in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 or older scheduled for elective surgery under general anesthesia who will receive rocuronium or vecuronium.
Not a fit: Patients with myasthenia gravis, Eaton-Lambert syndrome, or hypersensitivity to sugammadex or the neuromuscular blockers will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of sugammadex's effectiveness and safety, potentially improving postoperative care for patients undergoing general anesthesia.
How similar studies have performed: While this study is observational, previous studies on sugammadex have shown promising results regarding its effectiveness and safety in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female adults aged 19 or older * Is to undergo elective surgery under general anesthesia * Is planned to use rocuronium or vecuronium as an NMBA * Is planned for extubation before/after being moved to the recovery room * ASA physical status I - III * Patients who have signed the informed consent after receiving information about the purpose and method of this study Exclusion Criteria: * Has myasthenia gravis or Eaton-Lambert myasthenic syndrome * Has hypersensitivity to ingredients of sugammadex, rocuronium, or vecuronium * Has received an investigational product within 12 weeks from the study enrollment or has plans to participate in another clinical trial during the participation of this study. * Other subjects who are considered inappropriate to participate in this study by the judgment of the investigator.
Where this trial is running
Seoul, Seongbuk-gu
- Korea University Anam Hospital — Seoul, Seongbuk-gu, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Choon-Hak Lim, MD — Department of Anesthesiology and Pain Medicine, Korea University Medical Center, Seoul, Korea.
- Study coordinator: MyungSook Hong
- Email: mshong@boryung.co.kr
- Phone: +8227088238
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.