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临床试验/NCT07139730
NCT07139730尚未招募不适用

Effect of Nebulized Lignocaine on the Stress Response of Endotracheal Intubation in Pediatrics Undergoing Tonsillectomy Operation ; A Randomized Controlled Clinical Trial

Assiut University0 个研究点目标入组 70 人开始时间: 2025年9月1日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
effect on serum cortisol level 2 minutes after intubation

研究概览

简要总结

This randomized clinical trial aims to is examining the effect of preoperative nebulized lidocaine on the stress response to intubation, monitored by rise in serum cortisol level post intubation

详细描述

Endotracheal intubation is a routine and often critical procedure performed in patients who require airway management, particularly during surgeries, emergency interventions, or in cases of respiratory failure. While essential, the process of intubation can provoke significant hemodynamic changes in patients, including fluctuations in heart rate, blood pressure, and other vital parameters. These hemodynamic responses are primarily a result of the stimulation caused by the mechanical manipulation of the airway and the associated stress response. (1,2).

The stress response to intubation is mainly mediated by the sympathetic nervous system, leading to an increase in catecholamine release, which in turn causes an elevation in heart rate and blood pressure. In certain vulnerable populations, such as those with pre-existing cardiovascular conditions, these changes can be problematic and increase the risk of complications such as arrhythmias, myocardial ischemia, and cerebrovascular events. (2, 3).

Lignocaine is a local anesthetic that has been shown to have antiarrhythmic properties and can be administered through various routes to reduce the stress response associated with endotracheal intubation. It can be delivered intravenously or via inhalation through a nebulizer. The intravenous route (IV) is commonly used in clinical practice to provide systemic analgesia and reduce sympathetic stimulation. Nebulized lignocaine, on the other hand, delivers the drug directly to the airway and has been proposed as a potential alternative for reducing the hemodynamic impact of intubation while also minimizing systemic side effects. (4,5,6).

Previous studies have suggested that both intravenous and nebulized lignocaine may be effective in attenuating the hemodynamic response to intubation. However, there remains a gap in understanding regarding the comparative efficacy, optimal dosing, and side-effect profiles of these two administration methods. While both approaches have been used in various clinical settings, there has been limited research examining their direct effects and comparison in a controlled, randomized trial setting. (7) .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Year 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Elective tonsillectomy operation 2- pediaterics below 9 years old 3- ASA I OR II

排除标准

  • 1- emergency cases as bleeding tonsills 2- ASA III OR IV

研究组 & 干预措施

Effect of Nebulized Lignocaine on the stress Response of Endotracheal Intubation in pediatrics unde

Experimental

干预措施: Lignocaine 2% concentration solution (Drug)

结局指标

主要结局

effect on serum cortisol level 2 minutes after intubation

时间窗: baseline

effect on serum cortisol level 2 minutes after intubation to asses decrease in stress response

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Sayed Frag Ahmed

doctor

Assiut University

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