Effect of Intravenous Lignocaine vs Placebo on Hemodynamic Response During Intubation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- MAP
研究概览
简要总结
To assess the mean hemodynamic responses post-intubation in patients given intravenous lignocaine pre-intubation as compared to a placebo pre-intubation in patients undergoing laryngoscopy surgery
详细描述
After identifying the candidate, details will be carefully discussed with the subject. The subject (or, when necessary, the parent or legal guardian if the subject is younger than 18 years of age or under guardianship) will be read the approved protocol consent form. Patients who have given informed consent to participate in the study will be randomized into one of the two study arms one day before the procedure. The study team present will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I and II
- •Age 20-60 years
- •Mallampatti , II
- •All surgeries are done under GA
- •Both genders
- •Those patients giving informed consent
排除标准
- •Difficult airway assessed during pre-op anaesthesia assessment
- •Unanticipated difficult airway based on the previous history of difficult intubation
- •BMI >30,
- •Micrognathia and microglossia based on pre-op anaesthesia assessment,
- •Diabetic patient with autonomic dysfunction liver disease, cardiovascular disease, pheochromocytoma, Cushing syndrome
- •Patients who do not give informed consent
研究组 & 干预措施
Lignocaine group
This group will be given 1.5 mg/kg I/V lignocaine before intubation
干预措施: iv Lignocaine vs placebo (Drug)
Placebo
This group will be given 6 ml normal saline before intubation
干预措施: iv Lignocaine vs placebo (Drug)
结局指标
主要结局
MAP
时间窗: post-intubation 3 minutes to 10 minutes
mean arterial pressure
Pulse
时间窗: post-intubation 3 minutes to 10 minutes
Heart rate
次要结局
未报告次要终点