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临床试验/CTRI/2025/09/094238
CTRI/2025/09/094238尚未招募不适用

Preoperative frailty index and sarcopenia as predictors of postoperative cognitive dysfunction in elderly patients undergoing orthopedic surgery under spinal anaesthesia a prospective observational study.

Dr Divya S1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
115
试验地点
1
主要终点
Association between preoperative frailty measured by 5-factor Modified Frailty Index 5mFI and postoperative cognitive dysfunction.

研究概览

简要总结

This prospective observational study evaluates whether preoperative frailty 5mFI and sarcopenia hand grip strength predict postoperative cognitive dysfunction POCD in elderly patients undergoing orthopaedic surgery under spinal anaesthesia. Cognitive function will be assessed using Addenbrooke’s Cognitive Examination III ACE III preoperatively and at 24 & 72 hours postoperatively. The study aims to identify high-risk patients early, enabling targeted perioperative care and improved outcomes.

研究设计

研究类型
Observational

入排标准

年龄范围
65.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Scheduled to undergo elective orthopaedic surgery under spinal anaesthesia.
  • 2.Age 65 years and above 3.Belonging to American society of Anesthesiologists (ASA) class I, II, III 4.Able to provide informed consent 5.Had a baseline Addenbrooke’s Cognitive Examination-III (ACE-III) score of more than 88.

排除标准

  • 1.Use of sedatives or conversion to general anaesthesia 2.Active alcohol abuse or chronic opioid/substance abuse 3.Pre-existing diagnosis of moderate to severe dementia or other major neurocognitive disorders.
  • 4.History of psychiatric illness that may affect cognitive assessment (e.g., schizophrenia, major depression with psychosis).
  • 5.Patients with neuromuscular disorders affecting hand grip strength (e.g., Parkinson’s disease, stroke with motor deficits).

结局指标

主要结局

Association between preoperative frailty measured by 5-factor Modified Frailty Index 5mFI and postoperative cognitive dysfunction.

时间窗: Association between preoperative frailty measured by 5-factor Modified Frailty Index 5mFI and postoperative cognitive dysfunction measured by ACE III preoperative baseline and 24 hours and 72 hours after surgery.

次要结局

  • Association between sarcopenia assessed by hand grip strength & post operative cognitive dysfunction.(Association between sarcopenia assessed by hand digital dynamometer & postoperative cognitive dysfunction measured by ACE III preoperative baseline & 24 hours & 72 hours after surgery.)

研究者

发起方
Dr Divya S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Divya S

Sri Venkateshwaraa Medical College Hospital and Research Centre

研究点 (1)

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