Effect of Nebulized Lignocaine on the Stress Response of Endotracheal Intubation in Pediatrics Undergoing Tonsillectomy Operation ; A Randomized Controlled Clinical Trial
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
- 是
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
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
Mahmoud Sayed Frag Ahmed
doctor
Assiut University
