NCT02150759已完成不适用
Comparison Study of Analgesic Effects for Dexmedetomidine-fentanyl vs Dexmedetomidine-ketamine in Femur Proximal Fracture Patients
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
- 46
- 试验地点
- 1
- 主要终点
- Pain Score Using Five Scales
研究概览
简要总结
- Comparison study of analgesic effects for dexmedetomidine-fentanyl vs dexmedetomidine-ketamine
- lateral position for spinal anesthesia in femur proximal fracture patients
详细描述
- Dexmedetomidine (1mcg/kg)- fentanyl (1mcg/kg) vs dexmedetomidine (1mcg/kg) - ketamine (1mg/kg) 10 minutes loading.
- After 10 minutes of drug infusion, patients are prepared for spinal anesthesia.
- pain scale and quality of patient positioning are measured three times (lateral position, chest-knee position, intrathecal local anesthetics injection)
- When patients have severe pain during intraoperative period, fentanyl 50 mcg will be intravenously inject.
- Patients will be injected propofol 10mg when they have agitation signs during operation.
- vital signs, bispectral index, korean version of mini mental status examination, verbal rating scale,fentany/propofol consumption, frequency of intrathecal injection
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologists classification 1-3 patients
- •>20 years old
排除标准
- •patients refuse
- •dementia patients, cooperation difficult patients
- •anaphylaxis of dexmedetomidine, ketamine, local anesthetics
- •heart problem (bradycardia, atrioventricular block)
研究组 & 干预措施
Dexmedetomidine-ketamine
Experimental
Dexmedetomidine-ketamine group
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine-ketamine
Experimental
Dexmedetomidine-ketamine group
干预措施: Ketamine (Drug)
Dexmedetomidine-fentanyl
Active Comparator
Dexmedetomidine-fentanyl group
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine-fentanyl
Active Comparator
Dexmedetomidine-fentanyl group
干预措施: Fentanyl (Drug)
结局指标
主要结局
Pain Score Using Five Scales
时间窗: average 10-20 minutes
We want to compare pain score (five scales; 0=calm, 1=facial grimacing, 2=moaning, 3=screaming, 4=restlessness or agitation, unable to proceed) when patients are lateral position during spinal anesthesia.
次要结局
- Quality of Patient Positioning(average 10-20 minutes during spinal anesthesia)
研究者
Ki Hwa Lee
Assistant professor
Inje University
研究点 (1)
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