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临床试验/NCT04545099
NCT04545099Unknown不适用

Comparison of the Impacts of Sugammadex With Neostigmine on Patency of Laryngeal Opening (Glottic Aperture Angle)

Yonsei University0 个研究点目标入组 84 人开始时间: 2020年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
84
主要终点
Angle of vocal folds after administration of sugammadex or neostigmine 2) Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine

研究概览

简要总结

The aim of this study is to compare the degree of change in the angle of the vocal cords before and after administration of neostigmine or sugammadex. Moreover, we intend to compare the angle of vocal folds after administration of neostigmine or sugammadex.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

triple (Participant, Care Provider, investigator)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who undergoes elective surgery under general anesthesia with supraglottic airway device.

排除标准

  • Patients under 20 years old
  • Pregnant women
  • Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
  • Patients who refused the clinical trial
  • Patients with dementia or cognitive impairment
  • Patients with neuromuscular disorders impairing neuromuscular blockade
  • Renal dysfunction (estimated Glomerular Filtration Rate less than 30 ml/min/1.73m2)
  • Past history of allergic reactions to neostigmine or sugammadex
  • Patients with ASA class IV or higher
  • Robotic surgery, adenoid or tonsillectomy
  • Patients with moderate or severe asthma, pulmonary function tests with forced expiratory volume for 1second of 1 liter or less, patients with upper respiratory infection symptoms within 2 weeks before surgery, current smokers (within 1 month of smoking cessation is included.)

研究组 & 干预措施

Sugammadex

Experimental

Administration of Sugammadex

干预措施: Sugammadex (Drug)

Neostigmine

Active Comparator

Administration of Neostigmine

干预措施: Neostigmine (Drug)

结局指标

主要结局

Angle of vocal folds after administration of sugammadex or neostigmine 2) Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine

时间窗: 1-2 minutes after drug administration (inhalation, exhalation)

Degree of change in angle of vocal folds before and after administration of sugammadex or neostigmine

时间窗: 1) Just before drug administration 2) 1-2 minutes after drug administration (inhalation, exhalation)

次要结局

  • Time to recover from spontaneous breathing(immediately after drug(sugammadex or neostigmine) administration)
  • Time to extubation(immediately after drug(sugammadex or neostigmine) administration)

研究者

申办方类型
Other
责任方
Sponsor

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