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临床试验/NCT03779516
NCT03779516终止不适用

Effect of Preoperative Nebulized Lidocaine on Postoperative Sore Throat After Endotracheal Intubation

Antalya Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2018年12月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
110
试验地点
1
主要终点
Changes in the incidence of postoperative sore throat

研究概览

简要总结

The purpose of this study is to test the hypothesis that use of preoperative nebulized lidocaine is reduced the incidence of postoperative sore throat after endotracheal intubation.

详细描述

Adult patients undergoing video-assisted thoracic surgery (VATS) requiring double lumen tube (DLT) endotracheal intubation for one-lung ventilation (OLV) were enrolled in the study. Patients were randomized by means of computer-generated order randomization into two groups: Group C (those who received a saline solution as placebo delivered by nebulization) and Group L (those who received lidocaine delivered by nebulization).

At 1, 6 and 24 h after tracheal extubation, an observer blinded to treatments evaluated the patients in terms of sore throat and hoarseness. In addition, Patients' satisfaction, intraoperative and postoperative opioid and analgesics consumption and complaints such as dysphagia, nausea and vomiting were recorded. Hemodynamic variables such as blood pressure and heart rate were also recorded.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing video-assisted thoracic surgery requiring double lumen tube endotracheal intubation for one-lung ventilation
  • American Society of Anesthesiologists class 1,2 and 3
  • Ability to consent

排除标准

  • patients <18 years old
  • body mass index (BMI) <20 or >35 kg/m2
  • Mallampati grade 3 or 4
  • mouth opening < 3 cm
  • preexisting hoarseness or sore throat
  • coagulopathy
  • patient with upper respiratory tract infection

结局指标

主要结局

Changes in the incidence of postoperative sore throat

时间窗: 24 hours

Sore throat was assessed using a 0-100 mm visual analog scale (VAS), where a score of 0 represents no pain and a score of 100 reflects the worst pain imaginable.

次要结局

  • Postoperative analgesic consumption(24 hours)
  • Changes in heart rate(60 minutes)
  • whether the hoarseness was present or not(24 hours)
  • Changes in mean arterial pressure(60 minutes)
  • Intraoperative opioid consumption(60 minutes)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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