Evaluation of Nebulized Dexmedetomidine, Intranasal Dexmedetomidine and Nebulized Saline given pre-operatively to blunt intubation response during adult endotracheal intubation – A Randomized control trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To compare the haemodynamic parameters, post induction in patients receiving either nebulized dexmedetomidine, intranasal dexmedetomidine or nebulized saline.
研究概览
简要总结
General anaesthesia is associated with haemodynamic responses which manifests as elevated heart rate and blood pressure. This occurs during direct laryngoscopy and intubation considered to be due to sympathetic stimulation. Although it lasts for a few seconds it may persist up to 10 minutes.
These short-term haemodynamic changes usually result in little to no harm in healthy individuals. However, they may be detrimental to patients with reactive airways, hypertension, cerebrovascular diseases, coronary artery disease and myocardial insufficiency.Hence, numerous drugs have been studied and used to attenuate these responses in the past, namely intravenous opioids, beta blockers, lignocaine etc.
One drug which has shown promise in this regard is Dexmedetomidine, which is a highly selective alpha-2 agonist with sympatholytic, sedative, amnesic and analgesic actions. Dexmedetomidine has been studied in several dosages and routes, namely intravenous, nebulized, intramuscular and intranasal in order to attenuate pressor response in both adult and paediatric population.
Nebulized dexmedetomidine has been shown to have high bioavailability (approximately 65% in nasal mucosa and 82% in buccal mucosa). It has also been theorized to be safer than intravenous and intranasal routes, since intravenous dexmedetomidine is associated with hypotension and bradycardia.
Hence, we undertook this trial of nebulization and intranasal administration of dexmedetomidine and attenuation of hemodynamic response to laryngoscopy and intubation.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients aged 18-65, falling under ASA category 1 and 2 who will be undergoing elective surgery requiring endotracheal intubation as part of general anaesthesia will form the study population.
排除标准
- •Known allergy to dexmedetomidine Hypertensive patients on betablockers Severe cardiovascular, hepatic, or renal disease Pregnancy or lactation History of difficult intubation.
结局指标
主要结局
To compare the haemodynamic parameters, post induction in patients receiving either nebulized dexmedetomidine, intranasal dexmedetomidine or nebulized saline.
时间窗: At the end of study duration data will be collected study duration 12 months
次要结局
- To assess the change in requirement of propofol for induction in patients receiving dexmedetomidine.(At the end of study duration data will be collected study duration 12 months)
研究者
Dr Anitha Prashanth
Fortis Hospitals Limited
