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临床试验/CTRI/2024/11/077274
CTRI/2024/11/077274尚未招募4 期

Efficacy of pre-operative nebulization with Dexmedetomidine, Lidocaine and a combination of dexmedetomidine and lidocaine for prevention of stress response to laryngoscopy and Intubation

Chirayu Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2025年1月1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
174
试验地点
1
主要终点
HR, SBP, DBP, MAP, SpO2

研究概览

简要总结

Direct laryngoscopy and tracheal intubation following induction of anesthesia are associated with hemodynamic changes due to increased sympathoadrenal activity, which may result in hypertension and/or tachycardia. Although transient, this exaggerated response may precipitate hypertensive crises, myocardial ischemia, arrhythmias, or increase in intracranial pressure in susceptible individuals. Various drugs—including local anesthetics, beta-blockers, calcium channel blockers, and narcotic analgesics—have been tried to blunt the laryngoscopy and intubation response, with varied success.

Nebulisation with lignocaine has a direct inhibition of the airway reflexes and thus useful in prevention of stress response. Dexmedetomidine is a potent and highly selective alpha-2 receptor agonist with sympatholytic, sedative, amnestic, and analgesic properties. Its pleiotropic effects have led to its increasing use for reducing anaesthetic and analgesic requirements in the perioperative period. The efficacy of dexmedetomidine in decreasing the hemodynamic response to laryngoscopy and intubation has been studied through intravenous intranasal and intramuscular routes. Nebulized dexmedetomidine may offer an attractive alternative to both intravenous as well as intranasal routes of administration because drug deposition following nebulization takes place over nasal, buccal, as well as respiratory mucosa.

Multiple studies had compared intravenous dexmedetomidine and nebulized lignocaine for prevention of stress response to intubation, but limited literature had compared nebulized dexmedetomidine and lignocaine. The present study aims to compare the effect of pre-operative nebulization with dexmedetomidine and lignocaine on stress response to laryngoscopy and intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
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

  • American Society of Anaesthesiologists Physical Status Grades 1 and 2 Patients undergoing elective surgery under General Anaesthesia.

排除标准

  • ASA physical status 3 or more Body Mass Index more than 30 kilograms per square metre Emergency surgery Patients with anticipated difficult intubation Patients with unanticipated difficult intubation requiring more than 15 seconds or more than 1 attempt at laryngoscopy Known allergy to study drugs Patients on Antihypertensives or drugs which can be a cofounder.

结局指标

主要结局

HR, SBP, DBP, MAP, SpO2

时间窗: 1, 3, 5, 7 and 10 minutes post-intubation.

次要结局

  • Sedation level will be assessed using Ramsay Sedation scale.(Before and after Nebulization)

研究者

发起方
Chirayu Medical College and Hospital
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sagnik Datta Majumdar

Chirayu Medical College & Hospital, Bhopal

研究点 (1)

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