Optimal Effective Dose of Dexmedetomidine on Postoperative Delirium and Cognitive Function of Elderly Patients Planned For TKA Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Proportion of patients reporting at least a 50% reduction of Postoperative Delirium (measured by Confusion Assessment Method, Delirium Index) post-Total knee arthroplasty under sevoflurane inhalational anesthesia.
研究概览
简要总结
This study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (TKA). The study will compare the outcomes of patients receiving dexmedetomidine to those receiving a standard anesthetic or sedative, focusing on factors such as patient characteristics, surgical duration, and postoperative care. The research will explore the potential neuroprotective effects of dexmedetomidine and its ability to mitigate the risks associated with anesthesia and surgery in vulnerable elderly populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Severe chronic knee osteoarthritis inducing limitation of movement and required knee replacements;
- •Patients of American Society of Anesthesiologists Classification grades II-III;
- •Patients free of exclusion criteria.
排除标准
- •Patients of American Society of Anesthesiologists Classification grade >III;
- •Patients show a high risk for getting Post Operative Delirium or have severe cognitive dysfunction;
- •Patients had a history of uncompensated cardiac, renal, or hepatic diseases;
- •Patients had uncontrolled diabetes mellitus or hypertension;
- •Patients had other causes for limited movement;
- •Patients had autoimmune disease, coagulopathy, severe anemia with a hemoglobin concentration of <7 g%;
- •Patients had local bone disorders that may prevent prosthesis stability;
- •Patients had allergies or contraindications to the study drugs.
研究组 & 干预措施
Control Group
干预措施: Normal saline (Drug)
Group D-1
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Group D-1
干预措施: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) (Drug)
Group D-2
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Group D-2
干预措施: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) (Drug)
Group D-3
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Group D-3
干预措施: Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML) (Drug)
结局指标
主要结局
Proportion of patients reporting at least a 50% reduction of Postoperative Delirium (measured by Confusion Assessment Method, Delirium Index) post-Total knee arthroplasty under sevoflurane inhalational anesthesia.
时间窗: 3 months
次要结局
未报告次要终点
研究者
Ahmed B. Abo elkheer
Lecturer of Anesthesiology, Pain, and ICU Department
Tanta University