A Comperative study of Epidural vs Subarachnoid Block on Post Operative Cognitive Dysfunction on Elderly Frail Patients Posted For Lower Limb Orthopaedic Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To assess and compare postoperative cognitive function between Epidural and Subarachnoid block groups.
研究概览
简要总结
Total 60 patients will be assigned randomly into one of the two groups of
30 each as follows: Group S-Patients who underwent spinal anasthesia and Group E-
Patients who underwent epidural anasthesia.
In both the groups, post-operative cognitive function assessment will be done to assess
cognitive function in both groups. Secondary outcomes like frailty assessment parameters,
hemodynamic changes,to assess correlation between frailty and cognitive function.
The cognitive function will be assessed 30min preoperatively and 30 min after surgery, and then after,24hrs and 48hrs,72hrs, after surgery using pre-validated, the Hindi Version of Mini Mental State Examination (MMSE) in 10 dimensions with a total score of 30. Preoperative and postoperative pain is assessed by numerical scale rating, postoperative pain managed, based on NRS scale less than 3, for group S pain is managed with inj. Paracetamol 15mg/kg iv 8hourly and inj. Diclofenac 1.5mg/kg im 12hrly.For group E 0.125% inj. Bupivacaine 10ml is given over 15minutes for NRS Scale less than 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 65.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients scheduled for elective lower limb surgery.
- •2.Consent to participate.
- •3.Surgery time upto 2 hrs.
- •4.Patients having fraility score 5 or above.
- •5.ASA 2 and 3.
排除标准
- •1.Patients refusal.
- •Patient having dementia, Mini-Mental status examination score less than 24 clinical, dementia scale more than 1 before the surgery.
- •Communication difficulties such as blindness and deafness
- •Psychiatric illnesses or taking psychotropic drugs
- •History of alcohol and drug abuse
- •Being unable to complete questionnaires.
- •Contraindication to neuraxial anaesthesia.
结局指标
主要结局
To assess and compare postoperative cognitive function between Epidural and Subarachnoid block groups.
时间窗: 30 minutes before Surgery,30 minutes after Surgery,24hours after surgery,36 Hours after surgery,72 hours after surgery.
次要结局
- To assess the influence of frailty on the development of Post operative cognitive dysfunction.(To compare intraoperative haemodynamic stability between groups.)
研究者
Ankita Rastogi
Uttar Pradesh Institute Of Medical Sciences