Use of Ivabradine for Attenuation of Stressor Response following Laryngoscopy and Intubation in patient undergoing surgery under general anaesthesia in tertiary care hospital: a double blind placebo controlled randomized trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- the change in heart rate, blood
研究概览
简要总结
Patients undergoing elective surgical procedure under general anaesthesia
during the study period will be the population group. the study population will receive tab Ivabradine 1 hr before induction of anesthesia and hemodynamic parameter will be measured on specific time period.Research is still going on to evaluate the effectiveness of oral ivabradine in maintenance of hemodynamic stability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •All American Society of Anaesthesiology (ASA) physical status I, aged 18- 50 yrs posted for elective non cardiac surgery under general anaesthesia requiring endotracheal intubation who consent to be part of the study.
排除标准
- •Patient not giving consent for the study.
- •ASA status >II 6
- •Anticipated difficult intubation(Mallampati Class III and IV, thyromental height < 6 cm , inter-incisor distance <3cm and cervical instability.
- •Baseline BP <90/50mm Hg (65) or >140/85mm Hg (105)
- •History of syncope, palpitation, chest pain or cardiac/ respiratory illness, liver or renal dysfunction.
- •History of substance abuse.
- •Those with ECG abnormalities.
结局指标
主要结局
the change in heart rate, blood
时间窗: 24 hours of total study duration in each case starting from the oral intake of study drug.
pressure and MAP (mean arterial pressure) following laryngoscopy and
时间窗: 24 hours of total study duration in each case starting from the oral intake of study drug.
intubation, which shall be compared between the study and control group.
时间窗: 24 hours of total study duration in each case starting from the oral intake of study drug.
Unattenuated these changes can be 20% or more.
时间窗: 24 hours of total study duration in each case starting from the oral intake of study drug.
次要结局
- To assess incidence of side effects and complication if any due to study drug(24 hrs in postoperative period after intake of study drug)