Clinical trial
A Multicenter, Prospective, Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety in Non-interventional, Real-world Setting
Name
BR-SGD-OS-401
Description
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.
Trial arms
Trial start
2023-04-11
Estimated PCD
2025-03-01
Trial end
2025-08-01
Status
Recruiting
Treatment
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.
Size
7000
Primary endpoint
Re-administration rate of sugammadex
baseline~24 hours after administration
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 7000, 'type': 'ESTIMATED'}}
Updated at
2024-04-02
1 organization
Organization
Boryung Pharmaceutical