NCT01980069已完成不适用
A Double-blind, Randomized, Parallel Design Study to Compare the Effectiveness of Sugammadex Versus Neostigmine in Improving Surgical Condition in Subjects Undergoing Laryngeal Microsurgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- surgical condition
研究概览
简要总结
Investigators hypothesized that the surgical condition will be improved with the use of sugammadex in patients undergoing laryngeal microsurgery. Investigators will compare the effect of sugammadex and neostigmine on the surgical condition during laryngeal microsurgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients of age over 20 years
- •scheduled for laryngeal microsurgery under general anesthesia
排除标准
- •anticipated difficult intubation, cervical spine disease, neuromuscular disease, acute or chronic renal failure, liver cirrhosis or liver failure
- •history of allergy to nondepolarizing muscle relaxant
- •history of malignant hyperthermia
- •pregnant woman
- •body mass index over 35 kg/m2
研究组 & 干预措施
Neostigmine arm
Experimental
Neostigmine arm
干预措施: Neostigmine (Drug)
Sugammadex arm
Active Comparator
Sugammadex arm
干预措施: Sugammadex (Drug)
结局指标
主要结局
surgical condition
时间窗: up to 1 hour after the end of surgery
Primary outcome is the proportion of patients who have clinically acceptable surgical condition. The surgeon will evaluate the surgical condition as a surgical rating scale during surgery (extremely poor condition, poor condition, acceptable condition, good condition, optimal condition).
次要结局
未报告次要终点
研究者
研究点 (1)
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