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临床试验/NCT06368843
NCT06368843尚未招募不适用

Evaluating the Impact of Ketamine Gargling on Post Intubation Sore Throat: A Randomized Controlled Trial.

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年4月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Sore throat

研究概览

简要总结

Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction.

详细描述

Patients have ranked POST as the eighth most adverse effect during the postoperative period. Various methods, both non-pharmacological and pharmacological, have been explored to mitigate POST with varying degrees of success. Non-pharmacological approaches include using smaller-sized endotracheal tubes, lubricating the tube with water-soluble jelly, employing careful airway instrumentation, ensuring intubation after full relaxation, employing gentle oropharyngeal suctioning, minimizing intracuff pressure, and deflating the tracheal tube cuff completely before extubation, all of which have been reported to reduce the incidence of POST.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients from both sex and aged between 18 and 45 years.
  • All participants were scheduled for elective laparoscopic appendectomy or cholecystectomy under general anesthesia.
  • Classified as ASA (American Society of Anesthesiologists) I or II.
  • Intubation duration is less than 90 minutes.

排除标准

  • Patients classified as ASA III or higher.
  • Patients exhibiting symptoms of sore throat prior to entering the operating room, or presenting with any respiratory illness or signs of respiratory infection.
  • Patients who smoke.
  • Patients with a history of allergy to drugs used in this study.
  • Patients who are addicted to steroid drugs (inhaled or oral).
  • Patients with predicted difficult airway and intubation, indicated by a Mallampati score of II or higher.
  • Obese patients with a BMI exceeding
  • Patients with neurological diseases.

研究组 & 干预措施

the 1st group (K group)

the 1st group (K group) consisted of 46 patients who were instructed to gargle with a ketamine solution

干预措施: Gargle with ketamine (Drug)

结局指标

主要结局

Sore throat

时间窗: 2, 6, 12, and 24 hrs. postoperatively

A sore throat is characterized by pain, scratchiness, or irritation in the throat, typically aggravated by swallowing.

次要结局

  • Cough(2, 6, 12, and 24 hrs. postoperatively)
  • Hoarseness of voice(2, 6, 12, and 24 hrs. postoperatively)

研究者

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

Hussein Ali

lecturer in anesthesiology department

Al-Azhar University

研究点 (1)

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