Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Heart Rate Variability
研究概览
简要总结
Beta blockers have been shown to decrease the risk of intraoperative cardiac events in patients at high cardiac risk. However, they have also been associated with side effects (for instance, stroke.) The role of beta blockers in patients at intermediate cardiac risk undergoing surgery is controversial. Heart rate variability is a way of evaluating the cardiac function of a patient. Decreased heart rate variability is associated with early cardiac death in patients with congestive heart failure (CHF) and after a heart attack. It has been shown to transiently decrease in patients in hemorrhagic shock after trauma and returns to normal after resuscitation in trauma and burn patients. The investigators hypothesize that beta blockers will maintain pre operative heart rate variability in patients with intermediate risk of cardiac events during operative intervention with laparoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 40-75 years old
- •intermediate risk of adverse cardiac events:
- •renal insufficiency (CrCl < 60)
- •diabetes mellitus
- •two of the following:
- •age > 50
- •hypertension
- •hyperlipidemia
- •hypercholesterolemia
- •prior stroke
- •undergoing an elective laparoscopic abdominal surgery less than three hours:
- •cholecystectomy
- •ventral hernia repair
- •umbilical hernia repair
- •gastric bypass or gastric banding
排除标准
- •currently taking a beta blocker
- •prior heart attack
- •rhythm other than sinus on ECG
- •contraindication to beta blockers:
- •decompensated CHF
- •severe valvular disease
- •hypersensitivity to beta blockers
- •heart rate < 60
- •currently taking a calcium channel blocker
- •urgent or emergent surgery
研究组 & 干预措施
Beta blocker
These patients will be randomized to receive a standard dose of metoprolol (50mg) starting two weeks prior to surgery
干预措施: metoprolol (Drug)
结局指标
主要结局
Heart Rate Variability
时间窗: 2 weeks
次要结局
未报告次要终点
