Evaluation of the Effect of Preoperative Intravenous Amantadine Sulfate on the Postoperative Early Cognitive Functions in a Elderly Patient With Laparoscopic Radical Prostatectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Mini Menthal Test
研究概览
简要总结
Evaluation of the effect of preoperative intravenous administration of amantadine sulfate on the prevention of the development of early cognitive dysfunction in elderly patients undergoing laparoscopic radical prostatectomy
详细描述
Investigators believe that the preoperative prophylactic amantadine sulphate will reduce the incidence of postoperative cognitive disfunction (POCD) in patients with laparoscopic radical prostatectomy due to the neuroprotective effect, alertness enhancing effect and neuron protective effects.
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, Care Provider)
盲法说明
Randomise double blind placebo- controlled study
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA II-III Patient
排除标准
- •history of disease related to central nervous system, history of psychiatric disease, history of previous open heart surgery, history of previous craniotomy, renal insufficiency, hepatic failure, history of arrhythmia pre-applied standardized Mini Mental Test (sMMT) less than 24 points
研究组 & 干预措施
Amantadine Sulphate
200 mg ıv Amantadine Sulphate in 500 cc solution
干预措施: Amantadine Sulfate (Drug)
Placebo group
iv 500 cc %0.9 sodium chloride
干预措施: Placebo (for amantadine sulphate) (Drug)
结局指标
主要结局
Mini Menthal Test
时间窗: 24 hours after surgery
cognitive function scale, Patients will be administered 24 hours after surgery.
次要结局
- Verbal analog Pain Scores on rest and movement(48 hours after surgrey)
研究者
Gülen Güler
Professor
TC Erciyes University