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临床试验/NCT04142502
NCT04142502已完成不适用

Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia: Pilot Study

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月20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
发起方
入组人数
60
试验地点
1
主要终点
Serial heart rate variability

研究概览

简要总结

Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system, but the exact effects are not well known. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia.

详细描述

Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases parasympathetic activity and increases sympathetic activity. These imbalance of autonomic nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which are used for sedation during spinal anesthesia, also affect autonomic nervous system but the exact effects are not well known. Moreoever, the effect of spinal anesthesia combined with sedation agent on autonomic nervous system has not been evaluated. The purpose of this study is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia. The current study is prospective randomized pilot study. Patients are assigned to propofol group and dexmedetomidine group. Using electrocardiaogram analysis, the change of autonomic nervous system will be measured from preoperative to end of surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age 20~60 years old
  • Scheduled lower extremity surgery under spinal anesthesia

排除标准

  • Arryhthmia
  • Uncooperative patients
  • On medication: beta blocker, psychiatric medicine
  • Thyroid function abnormality

研究组 & 干预措施

Propofol group

Active Comparator

Using propofol as a sedation drug Infusion rate control Effect site concentration 0.3~1.0 mg/ml using target concentration infusion Bispectral index 60~80

干预措施: Propofol (Drug)

Dexmedetomidine group

Active Comparator

Using dexmedetomidine as a sedation drug First 10 minutes 1.0 mcg/kg loading After 10 minutes 0.3-1.0 mcg/kg/hr maintenance Bispectral index 60~80

干预措施: Dexmedetomidin (Drug)

结局指标

主要结局

Serial heart rate variability

时间窗: 40 minutes (before entering the operating room ~ 20 minutes after starting sedation

Serial change of frequency domain results from EKG RR interval Baseline: before entering the operating room T0: Preinduction T1: 10 minutes after spinal anesthesia T2: 10 minutes after starting sedation T3: 20 minutes after starting sedationi Frequency domain results Total power (ms2) Low frequency (ms2) High frequency (ms2) LF/HF ratio

次要结局

未报告次要终点

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

In-kyong Yi

Clinical Assistant Professor

Ajou University School of Medicine

研究点 (1)

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