Clinical evaluation of dexmedetomidine on haemodynamic stress response during laryngoscopy and intubation-a randomized, double blind, parallel group, placebo controlled study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Blunting in haemodynamic stress response during laryngoscopy and intubation.
研究概览
简要总结
Pressure response to laryngoscopy and intubation, resulting in stimulation of sympathetic nervous system leads to tachycardia and hypertension.Elevated plasma concentration of catecholamines due to sympathetic discharge increases HR,BP and myocardial oxygen demand, which may lead to haemodynamic instability. This response may be blunted by benzodiezepins,beta-blockers,opioids,nitroglycerine,etc.
Alpha2 receptor agonists may also be used for this purpose,with reducing the dose requirement of general anaesthetic agents. Dexmedetomidine is the selective and potent alpha2 agonist.
The aim of our study the effect of Dexmedetomidine on controlling the haemodynamic response to laryngoscopy and intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients posted for elective surgery under general anaesthesia requiring endotracheal intubation.
- •ASA physical status I and II.
- •BMI ≤ 25kg/m
- •Informed written consent for participation in study.
排除标准
- •Patients with diabetes, renal disease, cardiac diseases like IHD, Hypertension.
- •Patients on drugs, having effects on heart rate and blood pressure (sedatives, opioids, β blockers, calcium channel blockers) and anti-psychiatric drugs.
- •Pregnant women and lactating mothers.
- •Anticipated difficult intubation.
- •Intubation attempt lasting longer than 20 seconds.
结局指标
主要结局
Blunting in haemodynamic stress response during laryngoscopy and intubation.
时间窗: Blood pressure,heart rate,oxygen saturation are recorded starting from baseline to infusion and then upto 30 minutes after intubation.
次要结局
- Sedative effect after infusion.(Sedation score will be recorded baseline and then after infusion of drug till induction.)