Preoperative Frailty and Postoperative Neurocognitive Disorders in Geriatric Patients in Georgia

Recruiting

• Conditions: Frailty

• Registration Number: NCT06700291
• Lead Sponsor: New Hospitals Georgia

Brief Summary

The number of elderly people in the global population is growing, presenting an increasing challenge. Technological advances in medicine have made it possible to perform complex surgeries on geriatric patients, improving the viability of this age group. However, postoperative neurocognitive disorders represent the most common postoperative complications in this demographic, leading to increased morbidity and mortality, a reduced quality of life, and a heightened risk of dementia.

In high-income countries, studies have shown that preoperative frailty is associated with a cascade of postoperative disorders, including cognitive decline, delirium, dementia, and mortality. These complications negatively impact the community as a whole, healthcare staff and services, and the daily lives of those affected and their families. Perioperative neurocognitive disorders are linked to longer hospital stays, increased economic costs, reduced ability to work, and adverse consequences for family members and caregivers.

Frailty is a syndrome characterized by decreased reserve and resistance to stressors, resulting from cumulative declines in multiple physiological systems over time. This leaves individuals less capable of mounting a satisfactory response to stressful events. Frailty is most prevalent in the aging population, with its prevalence increasing exponentially with age.

This study will be the first to investigate preoperative frailty and its association with postoperative cognitive disorders in Georgia. Currently, there is limited information regarding the geriatric population in Georgia. The study will explore the prevalence of preoperative frailty and its impact on postoperative outcomes, including depression, dementia, cognitive dysfunction, delirium, and mortality at 30 days, three months, and one year following anesthesia and surgery.

This pioneering research will provide valuable insights into these disorders in low- and middle-income countries. It will fill a significant gap in the international literature by contributing essential knowledge that is currently lacking in this field.

Detailed Description

Investigators will conduct a prospective, observational cohort study to determine the prevalence of frailty in the geriatric population of Georgia, focusing on men and women aged 65 years and older undergoing elective orthopedic surgery. All participants will provide written, informed consent to participate in the study.

Frailty will be assessed using the Edmonton Frail Scale preoperatively, at discharge, three months, and one year postoperatively. Baseline cognitive function will be evaluated using the Mini-Cog test, while the Telephone Interview for Cognitive Status (TICS) will enable cognitive screening and the detection of pre-existing cognitive disorders. Postoperative neurocognitive disorders (NCDs) will also be assessed with TICS at one month, three months, and one year postoperatively through telephone follow-ups.

Delirium will be evaluated preoperatively and twice daily during the patient's hospital stay using the Three-Minute Diagnostic Interview for Confusion Assessment. If patients require intensive care postoperatively, the Confusion Assessment Method for the ICU (ICU CAM) will also be administered twice daily.

Depression will be measured with the Geriatric Depression Scale (GDS) preoperatively and postoperatively at discharge, and again at one month, three months, and one year. Anxiety will be assessed using a visual analogue scale at baseline, discharge, one month, three months, and one year. The Trail Making Test A and B will be administered preoperatively and at discharge. Pain levels will be measured during each assessment using the Numerical Rating Scale (NRS).

Disability and the ability to perform daily living activities (ADLs) will be evaluated at baseline, three months, and one year postoperatively using the WHO Disability Assessment Schedule (WHODAS).

Additionally, investigators will collect demographic and clinical information, including education level, comorbidities, alcohol use, lifestyle factors, and body mass index (BMI). Laboratory tests will also be conducted to explore potential mechanisms underlying postoperative neurocognitive disorders (PND), such as albumin, HbA1c, triglycerides, electrolytes, creatinine, Vitamin D, and interleukin-6 (IL-6).

All assessments and tests originally in English will be translated into Georgian and validated for the Georgian population before being administered to patients in the hospital.

Study Timeline

• Study Start: 2023-04-26
• Status Verified: 2024-11
• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Male or female patients aged 65y or more Scheduled for elective orthopedic surgery with knee or hip endoprosthesis.

Exclusion Criteria

Dementia Psychiatric diseases A history of surgery in the past six months and inability to undertake neuropsychological assessment (e.g. poor vision or hearing loss).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify the prevalence of preoperative frailty in a Georgian hospital and determine its association with postoperative neurocognitive disorders	3 years	Investigators will test frailty with a test in 65 years old patients who are going through planed orthopedic surgery preoperatively,on day of discharge, three moths and one year postoperatively.

Secondary Outcome Measures

Name	Time	Method
To identify correlation between preoperative demographic and co-morbid factors and postoperative neurocognitive disorders.	3 years	We will collect the history of patiants before the surgery and when the study is finished will check correlation of postoperative neurocognitive disorders with different co-morbid factors.

Trial Locations

Locations (1)

New Hospitals; 🇬🇪 Tbilisi, Georgia