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临床试验/NCT02993718
NCT02993718已完成不适用

Comparison of the Upper Airway Patency by Dexmedetomidine and Propofol Used for Sedation

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2015年1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
状态
已完成
入组人数
52
试验地点
1
主要终点
The occurrence of upper airway obstruction

研究概览

简要总结

Under the hypothesis that dexmedetomidine sedation would result in less upper airway obstruction, we evaluated the occurrence of upper airway collapse or the requirement of airway intervention in patients with obstructive sleep apnea during dexmedetomidine or propofol sedation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Surgery under spinal anesthesia
  • Intraoperative sedation
  • American Society of Anesthesiology physical status 1 or 2
  • Apnea/hypopnea index 5-14/h in Watch-PAT 200 analysis

排除标准

  • Anatomical defects on upper respiratory tract
  • Psychotic disorder
  • Drug addition
  • Alcohol addition
  • body mass index ≥ 35 kg/m2

研究组 & 干预措施

Dexmedetomidine

Experimental

Intraoperative sedation is performed by using dexmedetomidine.

干预措施: Dexmedetomidine (Drug)

Propofol

Experimental

Intraoperative sedation is performed by using propofol

干预措施: Propofol (Drug)

结局指标

主要结局

The occurrence of upper airway obstruction

时间窗: During the sedation period, an average of 3 hours.

When end-tidal carbon dioxide was not detected in spite of the respiratory effort during the sedation period, the case will be regarded as the occurrence of upper airway obstruction.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyo-Seok Na

Principal investigator

Seoul National University Bundang Hospital

研究点 (1)

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