Attenuation of pressor response to laryngoscopy and endotracheal intubation with oral Ivabradine versus intravenous Esmolol in American society of Anesthesiologist physical status grade I patients - Open label randomised control trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Heart rate,
研究概览
简要总结
Airway management is a critical skill for anesthesiologists, particularly during laryngoscopy and endotracheal intubation, which often trigger a cardiovascular stress response. This response, characterized by transient hypertension, tachycardia, and elevated serum catecholamines, can result in serious cardiovascular complications, especially in high-risk patients. Effective management of this pressor response is therefore essential to ensure patient safety and optimize outcomes during surgery.
Esmolol, a cardio-selective beta-blocker with a short half-life, has been widely studied for its ability to attenuate the pressor response and maintain hemodynamic stability. Conversely, Ivabradine, a selective inhibitor of the "If" current in the sinoatrial node, offers a unique mechanism of reducing heart rate without affecting myocardial contractility or blood pressure. Unlike beta-blockers, Ivabradine is suitable for use in patients with contraindications to beta-blockers, such as those with bronchial asthma, diabetes, or normotensive conditions.
While studies have established the individual efficacy of Esmolol and Ivabradine in blunting the cardiovascular stress response to intubation, no direct comparative study has been conducted to evaluate their relative effectiveness. This randomized controlled trial aims to bridge this gap by comparing oral Ivabradine and intravenous Esmolol in attenuating hemodynamic responses to laryngoscopy and intubation in ASA Grade I patients undergoing elective surgeries. The findings will provide evidence-based insights into optimal pharmacological interventions to minimize perioperative cardiovascular risks and refine anesthetic protocols.
RELEVANCE OF RESEARCH PROPOSAL TO PUBLIC HEALTH:
1. Understanding the comparative effectiveness of pharmacological interventions will directly contributes to enhancing patient safety during endotracheal intubation.
2. Identifying the most effective agent for blunting the pressor response ensures the delivery of high-quality care to patients, reduce the risk of cardiovascular complications associated with this procedure.
3. Anesthetic protocols play a pivotal role in ensuring positive perioperative outcomes. This research has the potential to influence and optimize anesthesia protocols.
4. By providing evidence-based insights into the comparative efficacy of esmolol and Ivabradine, the study will contribute to refining anesthesia practices, promoting standardization, and improving the overall quality of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •a.American Society of Anesthesiologists (ASA) –Physical Status grade I b.Patients with Mallampatti class I and II c.Patients with Normal ECG d.Patients Scheduled for elective non- cardiac surgery requiring endotracheal intubation.
排除标准
- •a.Patients refusal or not consented to participate in the study.
- •b.Patient with previous H/O Chest Pain/ Palpitations/Syncope c.Patient with H/o Respiratory Problems d.Patient with Hepatic or renal Problems e.Patient with Known allergies to Esmolol or Ivabradine f.
- •Patient with History of cardiac conduction abnormalities.
- •g.Patient with ECG abnormalities h.Patient with difficult airway i.Patient with Heart rate less than 60/minute and Systolic blood pressure less than 100mmHg j.Patient with total duration of laryngoscopy and intubation more than 20 seconds k.Patient with Mallampatti class III and IV Pregnant and lactating women.
结局指标
主要结局
Mean Heart rate,
时间窗: At base level, after study drug, after induction, after intubation, 1st minute, 3rd minute, 5th minute, 8th minute, 10th minute, 1st hour and 2nd hour
Mean Systolic blood pressure
时间窗: At base level, after study drug, after induction, after intubation, 1st minute, 3rd minute, 5th minute, 8th minute, 10th minute, 1st hour and 2nd hour
Mean diastolic blood pressure
时间窗: At base level, after study drug, after induction, after intubation, 1st minute, 3rd minute, 5th minute, 8th minute, 10th minute, 1st hour and 2nd hour
次要结局
- Adverse drug reaction(after 12 hours of study drug)
研究者
sundharalingam senthilraj
government medical college, nalgonda.