A study to evaluate the efficacy of nebulization with Dexamthasone and Lidocaine preoperatively on post operative sore throat(POST)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- The incidence of Postoperative sore throat at 4 hours post extubation
研究概览
简要总结
Postoperative sorethroat (POST) is a common adverseevent after general anesthesia especially with endotracheal intubation.Reported incidence of POST following general anesthesia is variable and rangesbetween 20-74%[1]. Aetiology is multifactorial which includespatient-related factors such as age, sex, smoking; and intubation factorsincluding technique, duration, number of attempts, tube size,intracuffpressure, cuff design, intraoperative tube movement, airwaymanipulations, and suctioning[2]. Mucosal damage by mechanical injurydue to airway manipulation and dehydration of the orophyrangeal mucosa areconsidered to result in post-operative sore throat . Postoperative sorethroat (POST) is a common adverseevent after general anesthesia especially with endotracheal intubation.Reported incidence of POST following general anesthesia is variable and rangesbetween 20-74%[1]. Aetiology is multifactorial which includespatient-related factors such as age, sex, smoking; and intubation factorsincluding technique, duration, number of attempts, tube size,intracuffpressure, cuff design, intraoperative tube movement, airwaymanipulations, andsuctioning[2]. Mucosal damage by mechanical injurydue to airway manipulation and dehydration of the orophyrangeal mucosa areconsidered to result in post-operative sore throatPostoperative sorethroat (POST) is a common adverseevent after general anesthesia especially with endotracheal intubation.Reported incidence of POST following general anesthesia is variable and rangesbetween 20-74%[1]. Aetiology is multifactorial which includespatient-related factors such as age, sex, smoking; and intubation factorsincluding technique, duration, number of attempts, tube size,intracuffpressure, cuff design, intraoperative tube movement, airwaymanipulations, and suctioning[2]. Mucosal damage by mechanical injurydue to airway manipulation and dehydration of the orophyrangeal mucosa areconsidered to result in post-operative sore throat.
Pharmacological measures for attenuatingPOST include use of topical, intravenous or inhalational agents.Variouspharmacological agents such as ketamine,benzydamine hydrochloride, lignocaine, magnesium and corticosteroids are usedto prevent POST. Locally used agents reduce airway inflammation by activeanti-inflammatory and analgesic properties when used preemptively and haveminimal systemic side effects.
In recent yearsnebulization with different drugs for POST have been used preoperatively andstudies have shown a reduction in the incidence and severity of POST. Due tosparing of bitter taste nebulization are better accepted and tolerated by thepatients. Requirement of small volume of drugs for effect, easy way ofadministration, better patient compliance, and very less risk of adverse eventsmakes nebulization therapy preferred choice over other methods such as gargle,intravenous etc
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients of ASA physical status I and II, age between 18 and 60 years of either sex, undergoing elective surgeries in supine position under General Anaesthesia with endotracheal intubation lasting < 3 hours will be enrolled in the study.
排除标准
- •Patients with recent sore throat(<14days) Patients with history of recent(<14days) use of steroids or NSAIDS.
- •Pregnant patients.
- •Patients with present chronic airway disease.
- •Anticipated difficult airway.
- •Patient refusal.
结局指标
主要结局
The incidence of Postoperative sore throat at 4 hours post extubation
时间窗: The incidence of Postoperative sore throat at 4 hours post extubation
次要结局
- Incidences & severities observed at 2 4 8 12 & 24 hours post surgery on a four point scale for(Any hoarseness of voice)