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临床试验/CTRI/2023/03/050187
CTRI/2023/03/050187尚未招募不适用

Comparison of the effectiveness of endotracheal instillation of lignocaine versus normal saline in prevention of cough during extubation after elective laparoscopic surgeries : A randomized control study

ESIC MEDICAL COLLEGE AND PGIMSR1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年6月3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
110
试验地点
1
主要终点
NUMBER AND GRADE OF COUGH

研究概览

简要总结

A typical clinical issue, coughing upon coming out of general anaesthesia can cause potentially harmful patient movements, hypertension, tachycardia or other arrhythmias, myocardial ischaemia, surgical haemorrhage, bronchospasm, and a rise in intracranial and intraocular pressure.

In individuals with coronary artery disease, cerebrovascular disease, or intracranial hypertension, coughing during extubation may have harmful implications.

Lidocaine is a local anaesthetic which has long been used to obtund intubation response. According to studies, stimulation of the larynx, trachea, and carina all result in haemodynamic abnormalities that lidocaine prevents. The larynx is the one that causes the greatest reaction among them.Endotracheal instillation of Lidocaine in the cuff in order to inflate the cuff prevents coughing and thereby prevents an increase in blood pressure and heart rate throughout the surgery. But repeated instillation may be required as it may get absorbed through the cuff. Endotracheal instillation of Lidocaine has been shown to obtund intubation response. Similar instillation through the endotracheal tube to obtund the response to extubation is sparsely studied.

The aim of the study is to investigate whether endotracheal instillation of lignocaine attenuates cough and airway circulatory reflex during extubation after elective laparoscopic surgeries requiring general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Double Blind Double Dummy

入排标准

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

入选标准

  • 1.Patient willing to give informed consent (Annexure-1) 2.American Society of Anesthesiologists (ASA) physical status I or II.
  • (Annexure 2) 3.Elective laparoscopic surgical procedures of a duration of 1-1.5hours under general anaesthesia with requirement for endotracheal intubation.

排除标准

  • 1.Patient with risk factors for difficult airway (mouth opening of <2cm, Mallampatti class 4, limited neck extension, history of previous difficult intubation) 2.Patients with known pulmonary and cardiovascular diseases.
  • 3.Patients having sore throat or active Upper Respiratory Infection (URI), history of laryngeal or tracheal pathology/surgery, history of asthma or Chronic Obstructive Pulmonary Disease(COPD).
  • 4.Known allergy to local anaesthetic.
  • 5.Patients on beta-blocker therapy.

结局指标

主要结局

NUMBER AND GRADE OF COUGH

时间窗: At base line (during extubation)

次要结局

  • HEART RATE AND BLOOD PRESSURE(EVERY MINUTE UPTO 10 MINS AFTER EXTUBATION)

研究者

发起方
ESIC MEDICAL COLLEGE AND PGIMSR
申办方类型
Government medical college

研究点 (1)

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