A Randomized study to compare the effect of Intravenous Dexmedetomidine versus Nebulized Lidocaine versus combination of Intravenous Dexmedetomidine with Nebulized Lidocaine on hemodynamic response for intubation in patients undergoing elective surgery under general anaesthesia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To determine the change in Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure and Rate Pressure Product within three groups
研究概览
简要总结
Study Universe - Patients undergoing elective surgery under general anaesthesia requiring endotracheal intubation
Study Population - Patients undergoing elective surgery under general anaesthesia requiring endotracheal intubation coming to SMS hospital
Screening, PAC written informed consent
inclusion
exclusion
Sample population (n=90)
Randomization will be done using computer-generated random number table
.
Group A(n=30): Patient will receive IV Group B(n=30): Patient will receive Group C(n=30): Patient
Dexmedetomidine and lidocaine IV Dexmedetomidine will be nebulized with
nebulization lidocaine
Haemodynamic variables Haemodynamic variables Haemodynamic variables
(HR,SBP,DBP,MAP) (HR,SBP,DBP,MAP) (HR,SBP,DBP,MAP)
Side effects Side effects Side effects
Statistical Analysis
Inference
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient undergoing elective surgery under general anaesthesia requiring endotracheal intubation 2.Patients consenting to participate 3.Adult patients 4.Patients belonging to American Society of Anesthesiologists (ASA) grade I and II.
排除标准
- •1.Patient should not be a part of other study 2.Non co-operative patient 3.Patients with difficult airway 4.Patients with cardiorespiratory comorbidity 5.Patients with smoking history 6.Patients on antihypertensive medication.
结局指标
主要结局
To determine the change in Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure and Rate Pressure Product within three groups
时间窗: To determine the change in Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure and Rate Pressure Product within three groups at 1, 3, 5, 7 and 10 minutes post intubation
次要结局
- To assess the side effects.(After completion of surgery the side effects like bradycardia, hypotension, bitter taste, dysphonia and oropharyngeal numbness within three.)
研究者
Dr Mamta Khandelwal
Sawai Man Singh Medical College, Jaipur