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临床试验/CTRI/2026/01/101404
CTRI/2026/01/101404尚未招募4 期

Comparative efficacy of different routes of administration of lignocaine on hemodynamic stress response during endotracheal intubation- a prospective randomized controlled trial

Bps gmc khanpur kalan sonipat1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年1月20日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1

研究概览

简要总结

Airway management is a cornerstone of safe anesthetic practice.Among the techniques employed, direct laryngoscopy and endotracheal intubation remain the gold standard for securing the airway during general anesthesia.However, despite its widespread use and clinical effectiveness, this procedure stimulates a sympathetic response.The underlying mechanism is the intense nociceptive stimulation of the upper airway, including the pharynx, larynx, and trachea.This leads to activation of the sympathoadrenal axis, resulting in tachycardia, hypertension, increased intracranial and intraocular pressures and elevated myocardial oxygen demand, especially concerning in patients with underlying comorbidities such as ischemic heart disease or cerebrovascular disorders.The hemodynamic changes associated with laryngoscopy and intubation occur rapidly—within 5 seconds of laryngoscopy, peaking at around 1–2 minutes, and typically resolving within 5 minutes. During this period, however, substantial physiological disturbances may occur.Studies have reported that heart rate can increase by 20–25 beats per minute, blood pressure by as much as 50– 55 mmHg, and left ventricular ejection fraction may transiently fall by up to 20%.

Over the years, multiple pharmacologic interventions have been employed to reduce the pressor response associated with intubation.These include opioids (e.g, fentanyl, alfentanil, remifentanil), vasodilators (e.g. nitroglycerine, nifedipine), beta-blockers (e.g, esmolol, labetalol), centrally acting alpha-2 agonists (e.g., clonidine, dexmedetomidine), magnesium sulphate, gabapentin, and local anesthetics such as lignocaine.Among these, lignocaine stands out due to its versatility, low cost, wide safety margin, and multiple routes of administration.Lignocaine acts by blocking voltage-gated sodium channels in neuronal membranes, thus inhibiting the initiation and propagation of nerve impulses.Lignocaine can be administered through three primary routes for airway anesthesia: Intravenous (IV): Systemically administered lignocaine has been shown to blunt sympathetic responses and reduce intraoperative awareness, but it has minimal local anesthetic effect on the airway mucosa. Nebulization (4%): This non-invasive technique distributes lignocaine aerosol throughout the airway, including the oropharynx, larynx, and proximal trachea, providing widespread mucosal anesthesia. Topical spray (10%): Offers rapid onset and localized anesthesia, typically applied to the posterior pharyngeal wall and laryngeal inlet. It is highly effective for short-term suppression of airway reflexes but may have limited reach in deeper structures.

In the current study, we aim to evaluate and compare the efficacy of three commonly used methods of lignocaine administration—2% intravenous lignocaine, 4% nebulized lignocaine, and 10% topical lignocaine spray—in suppressing airway reflexes and mitigating hemodynamic responses during endotracheal intubation

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 60.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I or II 2) Undergoing elective surgery under general anesthesia 3) Willing to provide informed consent.

排除标准

  • Anticipated difficult airway 1) ASA grade III or above 2) History of allergy to lignocaine 3) Pregnant or lactating women 4) Patients with cardiovascular instability or conduction abnormalities 5) Respiratory tract infections, asthma, or COPD.

研究者

发起方
Bps gmc khanpur kalan sonipat
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rahul

Bps gmc khanpur kalan, sonipat

研究点 (1)

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