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临床试验/CTRI/2024/08/072485
CTRI/2024/08/072485尚未招募不适用

The efficacy of intracuff instillation of 2% Lignocaine solution versus Air in Endotracheal Tube , in prevention of post operative sore throat, after surgery under General Anaesthesia - A Comparative Randomised Control Study.

Purbanil Baruah1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年8月21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
80
试验地点
1
主要终点
Decrease in the incidence of post operative sore throat

研究概览

简要总结

Endotracheal intubation is the gold standard for securing the airway in General  Anaesthesia. Endotracjheal tube (ETT) can be inserted either through the nose or through the mouth. The distal end of the  ETT lies in the mid trachea above the carina and it secures the airway and allows for the exchange of  gases during ventillation. This also allows for the delivery of inhaled anaesthetic agents for the maintenance of anaesthesia in the patient during the course of the surgery. The cuffed ETT is routinely used in most surgeries. The cuff is inflated to provide a seal in the trachea. This prevents aspiration to the lungs and also ensures the Tidal volume given to the lungs doesnot escape to the upper airway.

Sore throat is a common side effect of general anaesthesia. It is found in approximately 30 to 70 percent cases of tracheal intubation. The  post operative sore throat is caused due to the mucosal irritation of the ETT against the tracheal wall.

The ET tube cuff can act as a reservoir for the local anaesthetic agent . The local anaesthetic agent thus given diffuses slowly and causes subsequent anaesthesia of the undeerlying mucosa. Therefore  the topical anaesthetic agent thus applied can act as a novel technique to reduce adverse emergence phenomenon including post operative sore throat , coughing etc.

This study compares the effect of intra cuff instillation of lignocaine versus air in endotracheal tube  in prevention of  post operative sore throat in surgeries done under general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Double

入排标准

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

入选标准

  • The following patients will be taken for the study- Patients with ASA Grade 1 and
  • Patients whose intra operative time is less than 2 hours .
  • Patients with Mallampati Grade 1 and
  • Patients undergoing elective surgery under general anaesthesia .

排除标准

  • The following patients will be excluded from the study.
  • Patients who refuse to give consent to participate in the study. Patients with difficult intubation ( Mallampati Grade 3 and 4). Patients where intubation was done in 2nd attempt. Patients having laryngeal disease or where surgery is being done on the head , neck or face. Patients having known allergy to local anaesthetics agents. Patients already having hsitory of sore throat , bronchial asthma, URTI, COPD or any other disease of the airway. Patients who are uncoperative. Patients who vomited in the last 24 hours before surgery. Patients with ASA Grade 3 and
  • Patients who are pregnant.

结局指标

主要结局

Decrease in the incidence of post operative sore throat

时间窗: Post operative sore throat measured at 30 minutes , 2 hours and 24 hour after extubation.

次要结局

  • Decrease in the incidence of post operative hoarseness of voice.(Post operative hoarseness measured at 30 minutes and 12 hours after extubation.)
  • Decrease in the incidence of post operative cough(Post operative cough will be assesed at 0 minutes , 5 minutes and 30 minutes post extubation)

研究者

发起方
Purbanil Baruah
申办方类型
Other [Self sponsored]
责任方
Principal Investigator
主要研究者

PURBANIL BARUAH

Tezpur Medical College

研究点 (1)

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