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临床试验/CTRI/2025/07/090969
CTRI/2025/07/090969尚未招募2 期

Evaluation of dexmedetomidine nebulisation versus four percentage lignocaine nebulisation for attenuation of intubation response to laryngoscopy & endotracheal tube intubation: Prospective randomised controlled trial

Dr Neredukomma Sricharan1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年7月26日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare the efficacy & safety of nebulized dexmedetomidine, nebulized 4% lignocaine for blunting of pressor effect caused by laryngoscopy and endotracheal intubation.

研究概览

简要总结

Laryngoscopy and intubation trigger transient hemodynamic responses, including increased heart rate, blood pressure, and myocardial oxygen demand, due to somatovisceral reflexes. While generally well-tolerated in healthy patients, these changes can be harmful in individuals with cardiovascular or cerebrovascular conditions.

To mitigate this response, various agents such as opioids, beta-blockers, calcium channel blockers, vasodilators, and lidocaine have been used via intravenous, topical, or nebulized routes. Nebulization is preferred due to its fewer side effects and effectiveness in attenuating airway irritation.

Lidocaine, a local anesthetic, is widely used in nebulized form to blunt intubation-induced cardiovascular responses. Dexmedetomidine, an alpha-2 adrenoceptor agonist with sedative and sympatholytic properties, is also being explored for nebulized administration to avoid intravenous side effects like bradycardia and hypotension.

Ultrasonic nebulization is a promising technique that produces fine aerosol particles for deeper airway penetration, requiring lower doses and reducing toxicity risks. While lidocaine nebulization is well-studied, few studies have assessed ultrasonic nebulization of dexmedetomidine. This study aims to compare the efficacy of ultrasonic nebulization of dexmedetomidine versus 4% lidocaine in attenuating the pressor response to laryngoscopy and intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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

  • Patients requiring general anesthesia and tracheal intubation.
  • ASA grade I and II patients.
  • Duration of surgery less than 4 hours.

排除标准

  • Patient refusal
  • Emergency surgeries
  • Hemodynamically unstable patients
  • Pregnancy 5.Previous allergy to anesthetic agents.

结局指标

主要结局

To compare the efficacy & safety of nebulized dexmedetomidine, nebulized 4% lignocaine for blunting of pressor effect caused by laryngoscopy and endotracheal intubation.

时间窗: At baseline, 1 minute, 2 minutes, 3 minutes, 5 minutes, 7 minutes , 10 | minutes, after intubation

次要结局

  • To evaluate the post-operative complications occurring after intubation and laryngoscopy like sore throat, difficulty in swallowing, speech problems and side effects of anesthetic agents.(postoperative period within 24 hours)

研究者

发起方
Dr Neredukomma Sricharan
申办方类型
Other [ [Self]]
责任方
Principal Investigator
主要研究者

Dr Neredukomma Sricharan

Nizams Institute of medical sciences

研究点 (1)

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