Comparison of Lignocaine Nebulization versus Lignocaine Lozenges onhemodynamics during BlockBusterTM Airway Insertion in patients scheduled for GeneralAnaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To study the Heart Rate, Noninvasive Blood Pressure, ECG changes and Oxygen Saturation in
研究概览
简要总结
Securing airway is of utmost importance for an anaesthetist at the time of general anaesthesia. Laryngeal Masks Airways(LMAs) were introduced as an alternative to endotracheal tube to prevent trauma to the airway and decrease intubation response on hemodynamics of a patient during laryngoscopy. These hemodynamic responses can further be reduced by anaesthetising the airway. In this study, we use lignocaine to anaesthetise the airway by using 2 modes of drug delivery - nebulization and lozenges, and comparing which out of them is more efficient in blunting the hemodynamic response during LMA insertion ( We have used BlockBuster Airway for this study), by studying the Heart Rate, Blood Pressure and also the SpO2 of the patients.
Other parameters like ECG changes, anaphylactic reactions, systemic toxicity, circulatory disturbances and any neurological deficits will also be studied during the trial.
Over the next 1.5 years, we aim to study the above in a group of 100 ASA - I and II patients and conclude as to which out of the 2 interventions will serve a better overall modality as a mode of anaesthetising the airway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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 in age group of 18-60 years
- •American Society of Anaesthesiologists (ASA) Status I and II
- •Patients undergoing surgery requiring general anaesthesia with laryngeal mask airway not requiring any other laryngeal or pharyngeal intervention.
排除标准
- •Patients allergic to lignocaine hydrochloride
- •Patients with difficult airway with Airway difficulty score >8
- •Morbid obesity BMI > 35 kg/m2
- •Known airway pathology
- •Oropharyngeal surgeries
- •Surgery duration more than 3 hours
- •Patients at increased risk of aspiration like GERD, peptic ulcer, non fasting status
- •Previous upper gastrointestinal surgery
- •Known or anticipated difficult tracheal intubation or facemask ventilation
- •Cervical spine injury
- •Pregnant Patients.
结局指标
主要结局
To study the Heart Rate, Noninvasive Blood Pressure, ECG changes and Oxygen Saturation in
时间窗: All these parameters to be taken prior to intervention (baseline), immediately after intervention, at the time of airway insertion and 1 minute, 2 minutes, 3 minutes, 5 minutes and 10 minutes after airway insertion.
patients during BlockbusterTM LMA insertion
时间窗: All these parameters to be taken prior to intervention (baseline), immediately after intervention, at the time of airway insertion and 1 minute, 2 minutes, 3 minutes, 5 minutes and 10 minutes after airway insertion.
次要结局
- ECG Changes(ECG Changes- Before intervention, after intervention, at the time of securing airway, 1min, 2 min, 3 min, 5 min, 10 min after securing airway)
- Anaphylaxis, Systemic toxicity, circulatory disturbances, neurological impairments(Before intervention, after intervention, at the time of securing airway, 1min, 2 min, 3 min, 5 min, 10 min after securing airway)