Efficacy of two different doses of oral ivabradine for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation-a randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- 1)To measure heart rate 1 minute after intubation.
研究概览
简要总结
.Ivabradine is a very unique cardiotonic drug, it reduces the heart rate without hemodynamic changes
.Ivabradine inhibits the funny current (“If†channels) in sinoatrial nodal tissue that leads to decrease in the rate of diastolic depolarisation and consequently decreases heart rate without affecting blood pressure
.previous studies have shown at this doses (2.5mg and 5mg)of oral ivabradine decreases response to laryngoscopy and endotracheal intubation
.we assume that oral ivabradine at lower doses can attenuate the hemodynamic response to laryngoscopy and endotracheal intubation
Primary objective***:***
To estimate the efficacy of two different doses (2.5mg and 5 mg) of oral ivabradine for attenuation of hemodynamic response during laryngoscopy and intubation
Secondary objective:
To estimate incidence of side effects of ivabradine: bradycardia, visual disturbances like luminous phenomenon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients posted for elective surgeries under general anaesthesia 2)Mallampati grade 1 and 2 patients 3)American Society of Anaesthesiologists (ASA)I,II.
排除标准
- •1.Heart rate less than 60 beats per min and SBP less than 100 mmhg 2.Sick sinus syndrome, Ecg abnormalities, visual disturbances.
- •3.Calcium channel blockers, azoles, antifungals, antiretroviral drugs and macrolides 4.pregnancy and lactating females 5.Difficult Intubation and laryngoscopy more than 15 seconds.
结局指标
主要结局
1)To measure heart rate 1 minute after intubation.
时间窗: 1minute
次要结局
- 1)To measure heart rate 3min, 5min, 8min and 10 min after intubation.(2)To measure SBP, DBP, MAP after 1min, 3min,5min,8min,10min after intubation.)
研究者
Mulagapaka Raghuram Naidu
kalinga institute of Medical Sciences