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临床试验/NCT03322098
NCT03322098已完成不适用

Effect of Atropine or Glycopyrrolate on the Prevention of Bradycardia During Sedation Using Dexmedetomidine in Geriatric Patients Undergoing Total Knee Replacement Under Spinal Anesthesia

Yonsei University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2017年10月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Pulse rate

研究概览

简要总结

Patients undergoing total knee arthroplasty with spinal anesthesia are often sedated to reduce patient discomfort due to large noises during surgery and also to reduce anxiety. Most commonly used sedatives include propofol and midazolam, but these agents often cause hypotension or respiratory depression, especially in elderly patients. Dexmedetomidine is a selective alpha 2 adrenergic drug, which acts as a sedative and also has analgesia effects. In contrast to propofol or midazolam, dexmedetomidine rarely causes respiratory depression, and therefore is often used in critically ill patients in the ICU and also in patients undergoing simple procedures. Hemodynamically, dexmedetomidine evokes a biphasic blood pressure response with a short hypertensive phase and subsequent hypotension. Bradycardia is also observed in many patients, which may lead to more serious outcomes in elderly patients who often have multiple comorbidities. Therefore, drugs to prevent bradycardia during dexmedetomidine infusion may help patients maintain a more stable hemodynamic state. The present study aims to compare the ability of atropine and glycopyrrolate to prevent bradycardia during dexmedetomidine infusion in elderly patients undergoing knee surgery with spinal anesthesia.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 65 years or older undergoing total knee replacement surgery under spinal anesthesia.
  • ASA class 1-3

排除标准

  • Patients with coagulation abnormalities
  • End organ diseases of liver, lung or kidney
  • Severe aortic stenosis
  • High degree AV block
  • Heart failure
  • Patients on MAO inhibitors
  • History of seizures or epilepsy

研究组 & 干预措施

Atropine group

Active Comparator

Patients that receive atropine 0.01 mg/kg (max 0.5mg) before spinal anesthesia

干预措施: Atropine (Drug)

Glycopyrrolate group

Active Comparator

Patients that receive glycopyrrolate 0.004mg/kg (max 0.2 mg) before spinal anesthesia

干预措施: Glycopyrrolate (Drug)

结局指标

主要结局

Pulse rate

时间窗: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)

Measured as beats per minute, heart rate below 50 bpm or decrease of more than 30% from baseline is defined as bradycardia.

blood pressure

时间窗: From 5 minutes before spinal anesthesia~end of surgery (Intraoperatively)

Measured as mmHg, systolic blood pressure lower than 90 mmHg or decrease of more than 30% from baseline is defined as hypotension.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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