NCT05788718已完成不适用
A Multicenter, Prospective, Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety in Non-interventional, Real-world Setting
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,458
- 试验地点
- 1
- 主要终点
- Re-administration rate of sugammadex
研究概览
简要总结
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:
- Prescription pattern of sugammadex
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Re-administration rate of sugammadex
时间窗: baseline~24 hours after administration
The number and ratio of patients re-administered with sugammadex within 24 hours of the initial administration of sugammadex are evaluated.
次要结局
- Prescription pattern of sugammadex(baseline~24 hours after administration)
- Incidence rate of postoperative residual curarization (PORC)(TOFr<0.9)(at 3 and 30 minutes after administration of sugammadex)
- Incidence rate of postoperative residual curarization (PORC)(TOFr<1.0)(at 3 and 30 minutes after administration of sugammadex)
- Analysis of clinical factors affecting sugammadex re-administration(baseline~24 hours after administration)
- Incidence rate of respiratory complications related to postoperative residual muscle relaxation after surgery(time from the first administration of sugammadex ~ 24 hours after administration)
- TOFr before sugammadex administration(baseline~24 hours after administration)
- TOFr before extubation(baseline~24 hours after administration)
- Time surpassed from the expected dismissal time from the recovery room(baseline~24 hours after administration)
- Ratio of unplanned transfer to the intensive care unit(excluding lung surgery and heart surgery)(time from the first administration of sugammadex ~ 24 hours after administration)
- Incidence rate of adverse drug reaction(time from the first administration of sugammadex ~ 24 hours after administration)
- Incidence rate of serious adverse drug reaction(time from the first administration of sugammadex ~ 24 hours after administration)
- Time to extubation(baseline~24 hours after administration)
- Incidence rate of PONV(postoperative nausea and vomiting)(time from the first administration of sugammadex ~ 24 hours after administration)
研究者
研究点 (1)
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