Comparative efficacy of inhaled glycopyrrolate and intravenous glycopyrrolate for optimizing awake fibreoptic intubation conditions in adult patients a double blind randomized controlled trial
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
ANISH KRISHNA G
Armed Forces Medical College
