Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia: Pilot Study
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
- 否
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
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
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
In-kyong Yi
Clinical Assistant Professor
Ajou University School of Medicine
