The Effect of Ketamine on Postoperative Cognitive Dysfunction in Geriatric Patients Undergoing Orthopaedic Surgery Under Spinal Anaesthesia, a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- postoperative cognitive dysfunction
研究概览
简要总结
Available evidence suggests that there is no significant difference in the incidence of postoperative cognitive dysfunction POCD when general anaesthesia and regional anaesthesia are compared[13, 14]. To the knowledge of the investigators , no studies are examining the effects of ketamine on cognitive outcomes in the setting of spinal anesthesia.
Thus, the purpose of this study was to compare the cognitive status, as assessed by the SPMSQ, of elderly patients undergoing orthopaedic surgery under spinal anaesthesia before and after ketamine administration. The authors hypothesized that patients receiving ketamine would exhibit better cognitive performance.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •patients scheduled for orthopaedic surgery under spinal anaesthesia.
- •ASA physical status I to II.
排除标准
- •Patients with a history of psychosis, schizophrenia, nephropathy, uncontrolled blood pressure, uncontrolled hepatic disorders, or allergy to ketamine.
- •Patients With moderate to severe depression according to Yesavage abbreviated Geriatric Depression Scale,
- •Patients presented with postoperative delirium or required medications other than study drugs.
- •Ketamine administration is contraindicated.
研究组 & 干预措施
Ketamine
干预措施: Ketamine (Drug)
Control
干预措施: Placebo (Other)
结局指标
主要结局
postoperative cognitive dysfunction
时间窗: first postoperative day
cognitive status will be conducted with the Short Portable Mental Status Questionnaire SPMSQ preoperative and 2 hours after surgery.
次要结局
未报告次要终点
研究者
Mostafa Samy Abbas
associate professor of anesthesia
Assiut University