An Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety
NCT ID: NCT05788718
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6458 participants
OBSERVATIONAL
2023-04-11
2025-05-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Sugammadex
As this is a non-interventional study designed to collect data as part of routine clinical practice, the type and dose of neuromuscular blocking agents are all based on the clinician's judgment.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
19 Years
ALL
No
Sponsors
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Boryung Pharmaceutical Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Choon-Hak Lim, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology and Pain Medicine, Korea University Medical Center, Seoul, Korea.
Locations
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Korea University Anam Hospital
Seoul, Seongbuk-gu, South Korea
Countries
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Other Identifiers
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BR-SGD-OS-401
Identifier Type: -
Identifier Source: org_study_id
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