Efficacy of Dexmedetomidine intravenously versus perineurally as an adjunct to regional anaesthesia on post-operative cognitive dysfunction in elderly patients posted for orthopaedic surgery -A randomised controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- To assess the incidence of post-operative cognitive dysfunction using Montreal Cognitive Assessment (MoCA) Score in both the groups
研究概览
简要总结
The study is designed to compare the effect of Dexmedetomidine intravenously versus perineurally as an adjunct to regional anaesthesia on post-operative cognitive dysfunction in elderly patients posted for orthopaedic surgery.
The primary goal of the research is to compare the incidence of post-operative cognitive dysfunction in both the study groups using MoCA score at 72 hours post -operatively.
By comparing the effect of Dexmedetomidine intravenously versus perineurally as an adjunct to regional anaesthesia on post-operative cognitive dysfunction (POCD) in elderly patients posted for orthopaedic surgery , the intervention which decreases the incidence of POCD in elderly population posted for orthopaedic surgery could be determined which will help in it’s management in a timely manner, thus preventing permanent cognitive decline in some patients , better functional recovery, decreased hospitalization stay and overall decreased mortality rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 98.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients scheduled for elective proximal femur nailing.
- •American Society of Anaesthesiologist (ASA) physical status I-III .
排除标准
- •Patients with haemodynamic instability
- •Known history of psychiatric illness , previous history of dementia , delirium, head injury
- •History of allergy to anaesthetic drugs
- •Contraindications to regional anaesthesia
- •Failed Central Neuraxial Block
- •Patients with communication or hearing or speech impairment.
结局指标
主要结局
To assess the incidence of post-operative cognitive dysfunction using Montreal Cognitive Assessment (MoCA) Score in both the groups
时间窗: at 72 hours after surgery.
次要结局
- To compare the incidence of postoperative cognitive dysfunction using MoCA score
- Time taken to first ambulation is assessed.(0 hours post-operatively)
- To evaluate correlation of C-reactive protein levels with incidence of post-operative cognitive dysfunction in both the groups .(pre-operatively followed by post-operatively at 72 hours)
研究者
Dr Pragya Darshika
Kalinga Institute of Medical Sciences , Bhubaneswar