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临床试验/TCTR20190903005
TCTR20190903005已完成2 期

The efficacy of single-dose aescin in preventing postoperative sore throat compared to placebos: a double-blinded, randomized controlled trial

HRH Princess Maha Chakri Sirindhorn Medical Center0 个研究点目标入组 147 人开始时间: 2019年9月3日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
147

研究概览

简要总结

Single oral dose of 40 mg aescin extract could not reduce the incidence of POST in patients undergoing general anesthesia with ETT in the first postoperative 24 hours. It also did not reduce the severity of POST as compared to placebo. However, it could hasten the recovery from POST almost 2-fold within the first 24 hours with statistical significance.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 64 Years(—)
性别
All

入选标准

  • Age > 18-64 years.
  • American Society of Anesthesiologists physical status I-II
  • Elective gynecologic surgery, abdominal surgery, breast surgery, orthopedic surgery Supine surgical position and neutral neck position
  • Operation time more than 1 hour and less than 6 hours

排除标准

  • Known hypersensitivity to aescin and any drugs in this study
  • Glucose, galactose, fructose intolerance
  • Renal insufficiency/renal failure or kidney diseases
  • Preoperative sore throat
  • History of upper respiratory tract illness
  • Pre-existing pulmonary disease
  • History of psychiatric disorders
  • History of difficult intubation/suspected difficult airway
  • Excessive external laryngeal manipulation
  • Insert any equipment to oral cavity ex. Panendoscopy, ERCP, EGD, dilate esophagus, NG or OG insertion, nasal temperature probe
  • Patients who are already intubated before general anesthesia

研究者

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