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临床试验/NCT02952157
NCT02952157Unknown4 期

Effect on Postoperative Sore Throat of Lidocaine Jelly Application Over the Endotracheal Tube of Tapered-shaped Cuff

Keimyung University Dongsan Medical Center0 个研究点目标入组 210 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
210
主要终点
Number of participants with sore throat

研究概览

简要总结

Postoperative sore throat is a complication after general anesthesia requiring endotracheal intubation. The investigators will evaluate the efficacy of lidocaine jelly application on the endotracheal tube with taper-shaped cuff regarding postoperative sore throat.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-III
  • Patients scheduled for general anesthesia with endotracheal intubation
  • Patients scheduled for surgery which duration is expected to less than 3 hr

排除标准

  • Difficult airway
  • Rapid sequence induction
  • Recent sore throat
  • Recent upper respiratory infection
  • Chronic obstructive pulmonary disease
  • Chronic cough
  • Pregnancy
  • Allergy to lidocaine
  • Friable teeth
  • History of head and neck surgery
  • Multiple intubation attempts
  • Regional anesthetic agents
  • Gastric tube
  • Dexamethasone

研究组 & 干预措施

Control

Sham Comparator

Normal saline will be applied to the endotracheal tube.

干预措施: Normal saline application (Drug)

Lidocaine

Active Comparator

Lidocaine jelly will be applied to the endotracheal tube.

干预措施: Lidocaine jelly application (Drug)

结局指标

主要结局

Number of participants with sore throat

时间窗: At 24 hr

次要结局

  • Number of participants with hoarseness(At 1, 6, 12 and 24 hr)
  • Number of participants with vomiting(At 1, 6, 12 and 24 hr)
  • Number of participants with sore throat(At 1, 6, and 12 hr)
  • Number of participants with additional pain medication(At 24 hr)
  • Number of participants with throat numbness(At 1, 6, 12 and 24 hr)
  • Number of participants with dry mouth(At 1, 6, 12 and 24 hr)
  • Number of participants with cough(At 1, 6, 12 and 24 hr)
  • Number of participants with nausea(At 1, 6, 12 and 24 hr)

研究者

申办方类型
Other
责任方
Sponsor

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