The Effect of Perioperative Atenolol on Post-Operative Cytokines
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative levels of IL-6 and C-Reactive protein
研究概览
简要总结
Studies have shown that beta-blockers such as atenolol when given in the perioperative period reduce morbidity and mortality. One study showed that atenolol given just during the surgery period, seemed to improve outcomes up to 2 years later. This is hard to explain since beta-blockers act on the body by blocking the effects of adrenalin and thereby lowering heart rate and blood pressure.
This study is designed to find out if perioperative atenolol might exert its long term effects through an anti-inflammatory mechanism rather than by lowering heart rate and blood pressure. It is known that inflammation increases after surgery as part of the healing process. However, it is also becoming clear that low-grade chronic inflammation can also lead to long term adverse effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective abdominal, orthopedic, or gynecologic surgery
- •ability to give informed consent
- •ability to tolerate beta-blocker therapy
- •ability to comply with follow-up requirements
排除标准
- •currently receiving beta-blocker therapy
- •EKG documented 2nd or 3rd degree heart block
- •EKG documented sinus bradycardia
- •Serum creatinine > 2.0
- •current treatment asthma
- •history of rheumatoid arthritis
- •history of Crohn's disease
- •history of lupus
- •history of inflammatory cancer
研究组 & 干预措施
placebo
干预措施: placebo (Drug)
atenolol
干预措施: atenolol (Drug)
结局指标
主要结局
Postoperative levels of IL-6 and C-Reactive protein
时间窗: 6 hrs, 48 hrs, 6 weeks
次要结局
- IL-10, TNF-α(6 hrs, 48 hrs, 6 weeks)