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临床试验/CTRI/2024/07/070364
CTRI/2024/07/070364招募中不适用

A comparative evaluation of nebulized ketamine and nebulized magnesium sulfate for attenuating the post operative sore throat in patients undergoing surgery under general anaesthesia: A double blinded randomized clinical trial

Prem Kumar P1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2024年7月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
142
试验地点
1
主要终点
post operative sore throat

研究概览

简要总结

Despite the emergence of new airway devices in the recent years, rigid laryngoscopy and tracheal intubation still remains the gold standard in airway management. Tracheal intubation is a commonly used technique in general anaesthesia, but it can cause a few side effects, including sore throat and hoarseness. These symptoms, known as postoperative sore throat (POST) which occurs in 21–65% of patients receiving general anaesthesia (GA) with tracheal intubation. POST had been rated by patients as the eighth most adverse effect in the postoperative period. Although POST is a minor side effect and is self-limiting, it causes a great deal of patient dissatisfaction. So prophylactic management of POST is recommended to improve the quality of post- anaesthesia care, though the symptoms resolve spontaneously without any treatment in most of the cases.

A previously studies had shown comparison between magnesium and ketamine gargle efficacy in decreasing the incidence of POST, but nebulization is superior to gargle. In this study we compare the effect of Nebulized Ketamine and Nebulized Magnesium sulphate to prevent Post operative sore throat.

This study will be prospective, double blinded randomized clinical trial to compare the effects of Nebulized ketamine versus Nebulized Magnesium sulfate for the Prevention of Post operative sore throat. A total of 142 patients of either sex will be selected for the study and divided into 2 groups Group K will receive Nebulization of ketamine 50mg in 5ml Normal saline and Group M will receive Nebulization of Magnesium sulphate 250mg in 5ml Normal saline. The patients will be looked for Post operative sore throat and if present, will be scored as 0 = No sore throat, 1 = Mild sore throat, 2 = Moderate sore throat, 3 = Severe sore throat. The data will be entered in SPSS version 26.0 and analysed using ANOVA test or Pearson Chisquare test as where appropriate.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of either sex.
  • Patients of age group 18 to 65 years.
  • Patients of American Society of Anaesthesiologists (ASA) Physical grade I or II.

排除标准

  • Patients with history of post operative sore throat.
  • Patients with history of recent respiratory tract infection.
  • Patients with history of chronic obstructive pulmonary disease, asthma, head and neck surgery.
  • Patients with inserted nasogastric tube.
  • History of allergy to study drugs and recent NSAIDs medication and steroids.
  • Patient unwillingness/ refusal.

结局指标

主要结局

post operative sore throat

时间窗: Outcome will be assessed in post operative period at 0,2,4 hours

次要结局

未报告次要终点

研究者

发起方
Prem Kumar P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Prem Kumar P

Regional Institute of Medical Sciences Imphal Manipur

研究点 (1)

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Comparision of ketamine and magnesium sulfate... | 临床试验