跳至主要内容
临床试验/CTRI/2025/09/094842
CTRI/2025/09/094842尚未招募不适用

Comparative evaluation of the efficacy of Nebulized Dexmedetomidine as an additive to Nebulized lignocaine for difficult awake fibreoptic Intubation

Academic Investigator Initiated Project1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To compare the efficacy and safety of nebulized dexmedetomidine as an additive to nebulized lignocaine with respect to cough and gag reflex

研究概览

简要总结

Since the 1960s, awake fibreoptic intubation (AFOI) has been established as the gold standard for anticipated difficult tracheal intubation. AFOI usually requires good sedation, patient cooperation, and preserved spontaneous respiration. The conscious sedation is desirable to make this procedure more tolerable. Adequate airway preparation is essential to minimize patient discomfort, to optimize intubating conditions, and to ensure procedural success. This can be achieved in broadly two ways- topical administration of local anaesthetic and blockade of neural supply to oropharynx and larynx. Topical administration of local anaesthetic in the form of spray or gargle causes less discomfort and trauma to patients as compared to airway nerve blocks. Topical application by nebulization technique is one of the promising techniques used to anesthetize the airway. Various pharmacological methods have been reported to achieve conscious sedation for AFOI including fentanyl, midazolam, ketamine, propofol, remifentanil and dexmedetomidine.

The combination of moderate conscious sedation and regional anaesthesia has been more commonly used to relieve patient anxiety and to suppress the pharyngeal, laryngeal, tracheal, and bronchial reflexes during AFOI. Effect of lignocaine nebulization has been studied extensively.

 Dexmedetomidine is a highly selective and specific alpha 2 adrenoreceptor agonist and has properties making it suitable for AFOI. In addition to hemodynamic stability, anxiolytic and analgesic properties, it results in sedation while maintaining easy reusability, it also causes relaxation of bronchial smooth muscles thus reduces cough reflex and inhibits the salivary gland secretions. Dexmedetomidine demonstrates minimal respiratory depression.

 Nebulized dexmedetomidine administration allows rapid absorption through nasal, respiratory and buccal mucosa. The bioavailability is 65% through nasal mucosa and 82% through buccal mucosa.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18 years and above patients belonging to ASA category 1,2 and 3 undergoing elective surgery requiring awake fibreoptic orotracheal intubation as a part of general anaesthesia willing to participate and provide informed consent.

排除标准

  • Known allergy to dexmedetomidine or lignocaine Severe cardiovascular, hepatic or renal disease Sinus bradycardia or heart block Pregnancy or lactation.

结局指标

主要结局

To compare the efficacy and safety of nebulized dexmedetomidine as an additive to nebulized lignocaine with respect to cough and gag reflex

时间窗: At the end of study duration data will be collected study duration 12 months

次要结局

  • Hemodynamic stability, glottis closure, patient satisfaction scores, sedation level and incidence of adverse drug reactions like bradycardia or hypotension.(At the end of study duration data will be collected study duration 12 months)

研究者

发起方
Academic Investigator Initiated Project
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Priya Motiani

Fortis Hospitals Limited

研究点 (1)

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