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临床试验/NCT03984526
NCT03984526已完成4 期

Comparison of Effect of Atropine or Ephedrine Pretreatment for Preventing Bradycardia Under Sedation With Dexmedetomidine After Spinal Anesthesia in Elderly Patients

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2019年6月25日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

intravenous ephedrine 8mg pretreatment

干预措施: ephedrine 8mg (Drug)

Control group

Placebo Comparator

intravenous normal saline pretreatment

干预措施: normal saline (Drug)

Atropine group

Experimental

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

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

yun jeong chae

Principal Investigator

Ajou University School of Medicine

研究点 (1)

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