NCT02902380已完成不适用
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
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
- 52
- 试验地点
- 1
- 主要终点
- Stress hormone level
研究概览
简要总结
Surgical stress induces stress hormone release and sympathetic hyperactivation. Dexmedetomidine has sympatholytic effect and attenuates stress responses. This study investigate the effect of dexmedetomidine on stress responses and autonomic nervous system balance in patients undergoing major spine 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ
- •patient scheduled for major spine surgery
排除标准
- •ASA physical status Ⅳ
- •congestive heart failure
- •severe hepatorenal disease
- •insulin dependent DM(diabetes mellitus)
- •cancer or metastasis
- •pregnancy
- •problem with communication
研究组 & 干预措施
Dexmedetomidine Group
Experimental
dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery
干预措施: dexmedetomidine group (Drug)
Control Group
Placebo Comparator
0.9% saline infusion
干预措施: control group (Drug)
结局指标
主要结局
Stress hormone level
时间窗: 1 hour after the end of surgery
The levels of stress hormone including epinephrine, norepinephrine, cortisol, and glucose will be measured during spinal surgery.
次要结局
未报告次要终点
研究者
研究点 (1)
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