Efficacy of Ivabradine Versus Propranolol Premedication During Hypotensive Anesthesia in Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- amount of Blood loss
研究概览
简要总结
50 Patients, aged from 18 to 39 years, ASA physical status I and II, undergoing endoscopic sinus surgery will be enrolled in the study.The patients will be randomly allocated by simple randomization using a computer programme into two groups by closed envelope technique (having 25 patients in each group): GROUP (P): will receive oral propranolol (INDERAL® -propranolol hydrochloride Ph. Eur. 10mg manufactured by AstraZeneca Egypt under license of AstraZeneca UK), 10 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 10 mg tablet one hour before the induction of anesthesia.
GROUP (I): will receive oral ivabradine (Procoralan® 5mg manufactured by Servier laboratories, France), 5 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 5 mg tablet one hour before the induction of anesthesia.
详细描述
Aim of the work To compare efficacy of oral premedication with ivabradine versus propranolol before hypotensive anesthesia with nitroglycerin during endoscopic sinus surgery on reduction of reflex tachycardia.
Secondary aim:
- Compare the safety and incidence of side effects between both drugs.
- Compare the amount of nitroglycerin used, and blood loss between both drugs during endoscopic sinus surgery.
Patients and methods This study will be conducted in the Department of Anesthesia, ENT operating theater, Alexandria University Hospitals after being approved by the Departmental Research and Ethical Committee, and after obtaining informed consents from all patients.
50 Patients, aged from 18 to 39 years, ASA physical status I and II, undergoing endoscopic sinus surgery will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I and II, undergoing endoscopic sinus surgery
排除标准
- •Patients with cardiovascular disease (hypertension, congestive heart failure, and coronary artery disease).
- •Patients on beta-blockers.
- •Patients with the base line heart rate<60 beats per minute.
- •Patients with diabetes mellitus (DM).
- •Cerebrovascular insufficiency.
- •Coagulation defects.
- •History of renal or hepatic insufficiency.
- •Hypersensitivity to the study drugs.
- •Patients with history of bronchial asthma
研究组 & 干预措施
GROUP (P):
will receive oral propranolol (INDERAL® -propranolol hydrochloride Ph. Eur. 10mg manufactured by AstraZeneca Egypt under license of AstraZeneca UK), 10 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 10 mg tablet one hour before the induction of anesthesia.
干预措施: Propranolol (Drug)
GROUP (I):
will receive oral ivabradine (Procoralan® 5mg manufactured by Servier laboratories, France), 5 mg one tablet at 8:00 pm in the evening before the day of the surgery and one 5 mg tablet one hour before the induction of anesthesia.
干预措施: Ivabradine (Drug)
结局指标
主要结局
amount of Blood loss
时间窗: the procedure time
Intraoperative bleeding
Hemodynamic changes :
时间窗: Baseline before induction of anesthesia. - Every 30 min throughout deliberate hypotension till termination of NTG infusion. - 5 minutes after the end of deliberate hypote
Mean arterial blood pressure (MABP) in mmHg by invasive monitoring using GE monitor . • Heart rate: (beats / minute
次要结局
- incidence of Complications(the procedure time)
研究者
Yasser Mohamed Mohamed Osman
assistant professor of anesthesia Alexandria university
Alexandria University