An Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety

Launched by BORYUNG PHARMACEUTICAL CO., LTD · Mar 27, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called sugammadex, which is used to help patients recover from anesthesia after surgery. Specifically, the researchers want to understand how often sugammadex is prescribed, how well it works, and if it is safe for patients who have received certain muscle relaxants called rocuronium or vecuronium during surgery. The study is observational, meaning that researchers will collect information from patients as part of their regular care without giving any extra tests or treatments.

To be eligible for this study, participants must be adults aged 19 or older who are scheduled for elective surgery that requires general anesthesia. They should be planning to use rocuronium or vecuronium as part of their anesthesia and should be able to breathe on their own before or after moving to the recovery room. Patients with specific medical conditions, such as myasthenia gravis, or those who are allergic to the study medications, cannot participate. During the study, participants will be observed for 24 hours after receiving sugammadex to track its effects. This helps ensure that researchers gather valuable information while providing patients with standard care.

Gender

ALL

Eligibility 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.