Preoperative Colchicine, Dronedarone Or Amiodarone for Prophylaxis Against Postoperative Atrial Fibrillation in Patients Undergoing On-pump CABG; A Comparative Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AF
研究概览
简要总结
Atrial fibrillation in the postoperative period of myocardial revascularization surgery (AF-POMR) occurs in 10% to 65% of patients, increasing morbidity and mortality after surgery. is associated with an increase in hospital length of stay, and, thus, in costs,and can cause serious clinical complications, such as hypotension, heart failure, stroke and other thromboembolic disorders.Although not completely understood, the electrophysiological mechanism of AF-POMR is believed to be reentry.
详细描述
Aim of the study The aim of this work is to study the effect of preoperative Colchicine, Dronedarone or Amiodarone for prophylaxis against postoperative atrial fibrillation in patients undergoing on-pump CABG.
Patients and Methods
Type and site of the study:
This randomized double blinded clinical study will be carried out at Beni-Suef university hospital, after approval by the department of Anesthesiology, Pain management and Surgical ICU, the local ethics and research committee and other involved departments, faculty of medicine, Beni-Suef University.
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study population will include inpatients of the cardiothoracic department scheduled for CABG surgery, both sex, selected randomly according to American Society of Anesthesiologists(ASA) grade II and III
排除标准
- •- Liver dysfunction, pregnancy.
- •History of allergic reaction to any drug used in this study.
- •Emergency procedure
- •Preoperative dialysis
- •Patients on antiarrhythmic medications
研究组 & 干预措施
colchicine
Colchicine will be used at the dose of 1 mg orally, twice daily, preoperatively (1 days), and of 0.5 mg, twice daily, until hospital discharge
干预措施: Colchicine (Drug)
Dronedarone
Dronedarone (200 mg twice daily starting from day before operation till 5 days after)
干预措施: Dronedarone (Drug)
amiodarone
amiodarone (200 mg three times per day)21 administered 6 days prior to surgery through 6 days after surgery
干预措施: Amiodarone (Drug)
结局指标
主要结局
AF
时间窗: change from baseline rhythm at 6 days
incidence of AF
次要结局
未报告次要终点
研究者
doaa rashwan
Assistant profesor Doaa Rashwan
Beni-Suef University