NCT00600093终止2 期
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).
研究概览
简要总结
The purpose of this study is to determine whether administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a diagnosis of Parkinson Disease refered for surgery at our institution.
排除标准
- •Cardiac and neurosurgical procedures
- •Inability to sign informed Consent
- •allergy to Amantadine
- •Congestive heart failure
- •Arrythmia (including bradycardia below 55 bpm)
- •renal failure (creatinin above 1.5)
- •If a patient will develop agitation or delirium lasting longer then 8 hours he will not receive the second dose of amantadine.
研究组 & 干预措施
A
Experimental
干预措施: Amantadine (Drug)
结局指标
主要结局
Mortality, Surgical site infection, Pneumonia, Myocardial Infarction, Cerebral Vascular Accident (CVA).
时间窗: 28 days
次要结局
- UPDRS score(2,28 days)
- Pain (vas score), Analgetic drugs requirement(2 days)
研究者
研究点 (1)
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