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临床试验/NCT01330654
NCT01330654撤回不适用

Using Heart Rate Variability to Analyze the Effect of Beta Blockers on Intermediate Risk Patients Undergoing Laparoscopic Surgical Procedures

University of California, San Francisco1 个研究点 分布在 1 个国家开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

研究者

申办方类型
Other

研究点 (1)

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