Prevention of Postoperative Cardiac Arrythmias in Thoracic Surgery : Celiprolol Versus Diltiazem
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- incidence of early postoperative atrial fibrillation
研究概览
简要总结
Cardiac arrythmias are the most common cardiac complications after thoracic surgery. They are made primarily of postoperative atrial fibrillation (POAF).
They are associated with an increased risk of stroke, increased length of hospital stay and cost of care, and increased long-term mortality.
Randomized , single-blind prospective study in the anesthesia and intensive care department of Abderrahmen Mami hospital Ariana Tunisia comparing the efficacy of Diltiazem versus Celiprolol in the prevention of postoperative cardiac arrythmias in patients proposed for pneumonectomy and bilobectomy.
详细描述
Cardiac arrythmias are the most common cardiac complications after thoracic surgery. They are made primarily of postoperative atrial fibrillation (POAF).
They are associated with an increased risk of stroke, increased length of hospital stay and cost of care, and increased long-term mortality.
According to the American Association of Thoracic Surgery (AATS), interventions at high risk for FAPO (> 15%) are: anterior mediastinal mass resection, thoracoscopic lobectomy, thoracotomy lobectomy, pneumonectomy, pleurectomy, tracheal resection, emphysema bubble, bronchopleural fistula repair, lung transplantation and oesophagectomy. And it has been shown that the occurrence of postoperative atrial fibrillation is correlated with the extent of resection in case of lung resection surgery such as lobectomy or pneumonectomy.
Based on their multifactorial etiology, different pharmacological classes have been used for the prevention of POAF with varying degrees of success such as Amiodarone, Digoxin, Flecaine, Magnesium Sulfate, Beta Blockers, Calcium Inhibitors and Statins.
Recommendations were made for the prevention of POAF by the Society of Thoracic Surgeons (STS) in 2011 and the AATS in 2014 and concluded that Diltiazem is recommended for prevention and it is a Grade IIA for recommendations of 2011 and a grade IIB for the 2014 recommendations. Beta-blockers (BB) are recommended and it is a grade IIB for the 2011 recommendations. In addition, amiodarone is not recommended in case of pneumonectomy because of of its pulmonary toxicity for the 2011 recommendations and is ranked grade IIA for the 2014 recommendations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years Sinus rhythm preoperatively.
- •Surgery at high risk of atrial arrhythmia occurring postoperatively:
- •Bi-lobectomy
- •Pneumonectomie
排除标准
- •Signs of myocardial ischemia per or post operative.
- •Persistent postoperative hypotension requiring the use of catecholamines.
- •Persistent bradycardia
- •Decompensated cardiac insufficiency.
- •Acute intestinal obstruction.
研究组 & 干预措施
Celiprolol
receiving 1 tablet per day of celiprolol (Celiprol®) 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobecomty for 2 weeks.
干预措施: Celiprolol (Drug)
Diltiazem
receiving 1 capsule per day of diltiazem (Monotildiem® LP) 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobectomy for 2 weeks.
干预措施: Diltiazem (Drug)
结局指标
主要结局
incidence of early postoperative atrial fibrillation
时间窗: 14 days
次要结局
- incidence of other cardiac arrythmias and other complications(30 days)
研究者
MahmoudMARZOUK
Medical Doctor anesthesiology and intensive care
Abderrahmane Mami Hospital