NCT01979653撤回不适用
A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- hemodynamic stability
研究概览
简要总结
The purpose of this study is to compare midazolam-dexmedetomidine with dexmedetomidine alone for hemodynamic stability and quality of sedation in elderly patients under 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
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 65 years
- •ASA physical status class I-II
- •the patients who want sedation during elective lower limb surgery under spinal anesthesia
排除标准
- •contraindication to spinal anesthesia
- •neurologic or cognitive dysfunction
- •severe cardiovascular or pulmonary disease
- •refusal to participation
研究组 & 干预措施
dexmedetomidine alone
Experimental
dexmedetomidine 0.5 mcg/kg for 10 min + normal saline (volume-matched) bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion
干预措施: dexmedetomidine alone or dexmedetomidine + midazolam (Drug)
dexmedetomidine + midazolam
Experimental
normal saline (volume-matched) for 10 min + midazolam 0.2 mg/kg bolus + dexmedetomidine 0.2-0.4 mcg/kg/hr infusion
干预措施: dexmedetomidine alone or dexmedetomidine + midazolam (Drug)
结局指标
主要结局
hemodynamic stability
时间窗: 4 hour
comparison of bradycardia incidence
次要结局
- Modified Observer Assessment of Alertness/Sedation (MOAAS) scale(4 hour)
研究者
So Yeon Kim
Assistant professor
Severance Hospital
研究点 (1)
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