Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- The incidence of intervention for bradycardia
研究概览
简要总结
Spinal anesthesia is widely used for lower extremity surgery, and sedation is often required during surgery. For sedation, propofol, midazolam and dexmedetomidine are frequently used. Dexmedetomidine is a highly selective alpha 2 receptor agonist, and has sedating and analgesic effect. Compared with propofol and midazolam, it has little or no respiratory inhibition and hemodynamically stable. It also has the effect of reducing delirium in the elderly. Dexmedetomidine has also been reported to prolong the duration of sensory and motor blockade effects of spinal anesthesia. However, several studies have reported that administration of dexmedetomidine in spinal anesthesia increases the incidence of bradycardia.
In a study of healthy young adults, concurrent administration of atropine with dexmedetomidine in spinal anesthesia significantly reduced the frequency of bradycardia requiring treatment. However, in elderly patients, it is often reported that there is little response to atropine in bradycardia, and ephedrine is more effective in treating bradycardia than atropine in the elderly.
The investigators therefore compared ephedrine and atropine as pretreatment to reduce the incidence of bradycardia when using dexmedetomidine as a sedative in elderly patients undergoing 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
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 100 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) classification I-II
- •Undergoing orthopedic surgery under spinal anesthesia
排除标准
- •Contraindication for spinal anesthesia
- •Atrial fibrillation, atrial flutter
- •Cardiac valve disease
- •Neurologic disease
- •initial systolic blood pressure in operating room > 160mmHg
研究组 & 干预措施
Ephedrine group
intravenous ephedrine 8mg pretreatment
干预措施: ephedrine 8mg (Drug)
Control group
intravenous normal saline pretreatment
干预措施: normal saline (Drug)
Atropine group
intravenous atropine 0.5mg pretreatment
干预措施: atropine 0.5mg (Drug)
结局指标
主要结局
The incidence of intervention for bradycardia
时间窗: for 1 hour after spinal anesthesia
The number of treatment for bradycardia which is defined as heart rate under 50 beats per minute
次要结局
- The incidence of intervention for hypotension(for 1 hour after spinal anesthesia)
- Systolic/ mean/ diastolic blood pressure(for 1 hour after spinal anesthesia)
研究者
yun jeong chae
Principal Investigator
Ajou University School of Medicine
