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临床试验/CTRI/2025/10/096109
CTRI/2025/10/096109尚未招募4 期

Comparative efficacy of inhaled glycopyrrolate and intravenous glycopyrrolate for optimizing awake fibreoptic intubation conditions in adult patients a double blind randomized controlled trial

ANISH KRISHNA G1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2025年11月10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
84
试验地点
1
主要终点
Secretion Score

研究概览

简要总结

Awake fibreoptic intubation AFOI is a cornerstone of airway management in patients with anticipated difficult intubation such as those with limited mouth opening cervical spine instability or upper airway tumours

This is a double blind randomised controlled trial aims to address this gap by comparing the efficacy of inhaled glycopyrrolate versus intravenous glycopyrrolate in decreasing secretions

The study hypothesizes that nebulized glycopyrrolate may improve the fiberoptic view of upper airway and glottis by effectively suppressing airway mucus secretion thereby decreasing cough enhancing patient comfort and facilitating faster tracheal intubation

Inhaled glycopyrrolate is primarily used for chronic obstructive pulmonary disease COPD management due to its bronchodilator effects

It offers the advantage of localized airway effects without significant systemic side effects

Limited studies suggest that inhaled glycopyrrolate may provide effective secretion control for AFOI while reducing systemic anticholinergic side effects

There is a paucity of studies comparing inhaled and intravenous glycopyrrolate specifically in the context of AFOI

If inhaled glycopyrrolate proves effective it may offer an alternative with fewer systemic side effects and better patient comfort

This study will provide evidence to guide anaesthetic practice in optimizing AFOI conditions

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
19.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients with anticipated difficult airway requiring AFOI and ASA physical status I to III.

排除标准

  • Allergy to glycopyrrolate Severe cardiac arrhythmias or uncontrolled tachycardia or bradyarrhythmia History of chronic respiratory disease affecting on treatment with anticholinergics Patients with altered mentation unable to comprehend the procedure cooperate or give consent Myasthenia gravis Patients using Contact lenses Patients with prostatic diseases Glaucoma.

结局指标

主要结局

Secretion Score

时间窗: outcome will be accessed immediately while 01min to 10min of intubation time | Intraoperative Haemodynamic parameters will be accessed baseline,15min,30min,45min,60min interval | post op side effects will be monitored 15min after extubation

Glottic visualization

时间窗: outcome will be accessed immediately while 01min to 10min of intubation time | Intraoperative Haemodynamic parameters will be accessed baseline,15min,30min,45min,60min interval | post op side effects will be monitored 15min after extubation

To compare the efficacy of inhaled and intravenous glycopyrrolate in

时间窗: outcome will be accessed immediately while 01min to 10min of intubation time | Intraoperative Haemodynamic parameters will be accessed baseline,15min,30min,45min,60min interval | post op side effects will be monitored 15min after extubation

improving AFOI conditions, assessed using

时间窗: outcome will be accessed immediately while 01min to 10min of intubation time | Intraoperative Haemodynamic parameters will be accessed baseline,15min,30min,45min,60min interval | post op side effects will be monitored 15min after extubation

次要结局

  • Time taken to reach carina(To evaluate the hemodynamic effects heart rate & blood pressure)

研究者

发起方
ANISH KRISHNA G
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

ANISH KRISHNA G

Armed Forces Medical College

研究点 (1)

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