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临床试验/NCT04247360
NCT04247360Unknown不适用

Effect of Cuff Pressure During Operation on Postoperative Sore Throat

Keimyung University Dongsan Medical Center0 个研究点目标入组 138 人开始时间: 2020年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
138
主要终点
postoperative sore throat

研究概览

简要总结

When general anesthesia is performed for surgery, tracheal intubation is performed. In order to ventilate after performing tracheal intubation, air is injected into the cuff attached to the tube to fill the gap between the tracheal tube and the patients's inner surface of trachea.

Even though, 20 to 30 cm H2O is known to be the appropriate pressure to prevent air leaks while preventing ischemic damage of tracheal mucosa. So, Researchers want to observe clinical differences in pressure at both ends of the safety zone of the cuff pressure.

详细描述

Patients who are scheduled for elective surgery/ general anesthesia are randomized to two groups.

l : cuff pressure - 20cmH2O ll : cuff pressure - 30cmH2O

After tracheal intubation with routine method, cuff pressure is continuously monitored with manometer. The anesthesia during surgery is maintained with 0.8 MAC of desflurane and continuous remifentanil. Clinical outcomes (sore throat, hoarseness and postoperative pain) are evaluated after 0 minutes, 2 hours, 4 hours, and 24 hours after surgery.

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
None

入排标准

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

入选标准

  • patients undergoing total hip replacement arthroplasty that require general anesthesia

排除标准

  • a patient who disagrees with the study
  • tracheal stenosis
  • operation time > 3 hours or < 1 hour 30 minutes
  • difficult airway
  • drug abuse, alcoholism

结局指标

主要结局

postoperative sore throat

时间窗: At postoperative 24 hours

Number of participants with postoperative sore throat for postoperative 24 hours

次要结局

  • postoperative hoarseness(At postoperative 24 hours)
  • nausea(At postoperative 24 hours)
  • Requirements of analgesics(At postoperative 24 hours)

研究者

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

Jiwon Lee

assistant professor

Keimyung University Dongsan Medical Center

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