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临床试验/CTRI/2024/06/068918
CTRI/2024/06/068918尚未招募不适用

Comparison of Nebulised Dexmedetomidine, Magnesium sulphate And Dexamethasone in Prevention of Postoperative Sore throat After Tracheal Intubation in Adults: A Double-blind Randomized Control Study

All India Institute of Medical Sciences Patna1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2024年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
220
试验地点
1
主要终点
Compare the incidence of Post Operative Sore throat within 24 hours of tracheal extubation.

研究概览

简要总结

Post-operative sore throat (POST) is one of the undesirable outcomes that occurs in patients following General anesthesia with endotracheal intubation. The incidence of POST varies from 14% to 50% following endotracheal intubation**.** Several risk factors have been identified for developing POST following endotracheal intubation including obesity, female sex, size of endotracheal tube, prolong duration of surgery, multiple intubation attempts, emergency intubation in intensive care unit (ICU). The intubation technique results in pathological changes including epithelial loss, glottic oedema, submucosal tears, and contact ulcer granuloma, which play an important role in POST development . Although it is self-limiting, it needs to be prevented because it seriously affects patient satisfaction and postoperative recovery. Despite the emergence of clinical trials on POST nebulization therapy, still no current overview of all the relevant drugs.Even there is lack of direct comparisons of these frequently used aerosolized drugs and lack of a clinically useful ranking of all atomizing drugs concerning both efficacy and acceptability. So in this study comparison between Nebulized Dexmedetomidine, Nebulized Magnesium sulphate and Nebulized Dexamethasone may be equally effective in the prevention of POST.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing surgeries with tracheal intubation lasting for more than 1 hour and less than 2 hours ASA PS I and II Adult normotensive patients.

排除标准

  • Patient refusal Patients allergic to any of the study drugs Patient with any upper respiratory tract infection Patients with anticipated difficult intubation ASA PS III and IV (Uncontrolled Diabetes) Patients requiring more than 15 seconds of intubation Two attempts of laryngoscopy or more.

结局指标

主要结局

Compare the incidence of Post Operative Sore throat within 24 hours of tracheal extubation.

时间窗: 0 hour | 30 minutes | 4 hours | 24 hours

次要结局

  • To measure the severity of Post Operative Sore throat (Moderate & Severe) by using a standard scoring system.
  • To note any other laryngeal complications such as cough, or hoarseness of voice observed within 24 hours of tracheal extubation.
  • To find out any difference in systolic, diastolic & Mean arterial Blood pressure changes from baseline.

研究者

发起方
All India Institute of Medical Sciences Patna
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dinesh S

AIIMS Patna

研究点 (1)

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