Clinical trial NCT06700291: Preoperative Frailty and Postoperative Neurocognitive Disorders in Geriatric Patients in Georgia
Official title: Preoperative Frailty and Postoperative Neurocognitive Disorders in Geriatric Patients in Georgia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Keywords: Delirium,
Perioperative neurocognitive disorder
Geriatric anaesthesia
Dementia
Frailty
Lead sponsor: New Hospitals Georgia
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 230
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male or female patients aged 65y or more, scheduled for elective orthopedic surgery with knee or hip endoprosthesis.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: To identify the prevalence of preoperative frailty in a Georgian hospital and determine its association with postoperative neurocognitive disorders
timeFrame: 3 years
Secondary outcomes:
measure: To identify correlation between preoperative demographic and co-morbid factors and postoperative neurocognitive disorders.
timeFrame: 3 years
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: New Hospitals
Study officials:
affiliation: David Tvildiani Medical University
name: Tamar Macharadze, Dr
role: PRINCIPAL_INVESTIGATOR
References: