CompletedNot Applicable

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

South Korea6,458 participantsStarted 2023-04-11

Plain-language summary

The purpose of this observational study is to evaluate patients who are planning to administer sugammadex after rocuronium or vecuronium is used. The main questions it aims to answer are: 1. Prescription pattern of sugammadex 2. Effectiveness and safety of sugammadex Since this study is observational, only data generated under daily treatment are to be collected, and no additional tests or drug administration is conducted for the study. The patients are observed from baseline to 24 hours after the initial administration of sugammadex.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Re-administration rate of sugammadex

Timeframe: baseline~24 hours after administration

Trial details

NCT IDNCT05788718

SponsorBoryung Pharmaceutical Co., Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05-08

View on ClinicalTrials.gov More Postoperative Complications trials