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临床试验/NCT01857141
NCT01857141已完成不适用

Comparative Study on the Effects of Epidural Dexmedetomidine on Heart Rate Variability During General Anesthesia in Patients Undergoing Gastrectomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2012年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Heart rate variability analysis

研究概览

简要总结

The use of epidural dexmedetomidine decreases the anaesthetic requirements and improved postoperative pain. Dexmedetomidine is a potent and highly selective a2-adrenoceptor agonist and has sympatholytic effect. Power spectral analysis of heart rate variability(HRV) is a useful tool to assess cardiac autonomic activity. We investigated whether preemptive epidural dexmedetomidine can develop hemodynamic change and it could be identify patients by HRV.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients consented to spinal anesthesia were enrolled
  • Patients aged 40~70 years olds undergoing gastrectomy
  • No contraindication of epidural analgesia
  • ASA class I and II
  • Patients consented to epidural anesthesia were enrolled

排除标准

  • Patients with hypovolemia, coagulation disorders, local infection at the site of operation, history of headache, heart diseases, and history of allergy, chronic alcohol use or abuse, anemia, congenital heart diseases, bundle block, congestive heart failure or arrythmias
  • patients who had recently received sedative drugs or were under antidepressant treatment were not included in the study

研究组 & 干预措施

dexmedetomidine

Experimental

干预措施: preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg) (Drug)

normal saline

Placebo Comparator

干预措施: normal saline (Drug)

结局指标

主要结局

Heart rate variability analysis

时间窗: 5min perioids after fluid resuscitation.

Heart rate variability analysis was performed according to the Task Force recommendations. Frequency domain analysis was based on fast Fourier transformation. Power spectrum densities were calculated for low frequencies (LF: 0.04-0.15 Hz) and high frequencies (HF: 0.15-0.4 Hz) informalized units, defined as the LF or HF proportional part of the total power. Baseline and 30min after the injection of the study drug.

次要结局

  • Epidural injection(at 30 min after the epidural injection of the study drug)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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