Preoperative Frailty and Postoperative Neurocognitive Disorders in Geriatric Patients in Georgia

NCT06700291 | Recruiting

• 1 other identifier: 01/01
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

Delirium,; Perioperative neurocognitive disorder; Geriatric anaesthesia; Dementia; Frailty

Outcome Measures

Primary Outcomes (1)

• Determine the prevalence of preoperative frailty

  Frailty will be assessed using the FRAIL scale in patients aged 65 years and older undergoing planned orthopedic surgery and will be conducted at four time points: preoperatively, on the day of discharge, and at 3 and 12 months postoperatively.

  Frailty assessments will be conducted at baseline preoperatively, on the day of hospital discharge (dependes how many days the patient stay in the hospital), and during follow-up at 3 months and 12 months post-surgery.

Secondary Outcomes (9)

• Correlation between preoperative frailty and postoperative disorders (postoperative delirium, delayed neurocognitive recovery and postoperative neurocognitive disorder) up to one year after surgery .

  Frailty: preop, within 12h prior to hospital discharge, and 3 & 12 mo postop; TMT A/B: baseline, within 12h prior to discharge; TICSm: 1, 3 & 12 mo postop; 3D-CAM & ICU-CAM: twice daily from postop day 1 until within 12 hours prior to discharge.

• Preoperative demographics and risk factors, including but not limited to age, level of education, and comorbidities, and their correlation with any perioperative neurocognitive disorders up to twelve months following surgery.

  Demographic information and risk factors will be collected on baseline.Postopereative outcomes will be collected on the day of discharge from the hospital,1 months, 3 months and 1 year after the surgery.

• Prevalence of preoperative cognitive impairment

  MoCA and TICSm - preoperative;

• Correlation between preoperative cognitive impairment and postoperative disorders (postoperative delirium, delayed neurocognitive recovery and postoperative neurocognitive disorder) up to one year after surgery

  MoCA and TICSm - preop; TICSm-1,3 and 12 mo postop. 3D-CAM: twice daily from postop day 1 until within 12h prior to hospital discharge; ICU-CAM: twice daily while in ICU; TMT A/B: preop baseline and within 12h prior to discharge regardless of stay length

• Determine the prevalence of depression in older adults presenting for anesthesia and surgery.

  Assessment time points: preoperative baseline

Interventions

Surgery PROCEDURE

Patient undergoing Anesthesia and Surgery

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Male or female patients aged 65 years or older
• Scheduled for elective orthopedic surgery (hip or knee arthroplasty with endoprosthesis)
• Able to provide informed consent

You may not qualify if:

• Diagnosis of dementia (any type)
• Major psychiatric disorder (e.g., schizophrenia, bipolar disorder, severe depression)
• Surgery performed within the past 6 months
• Inability to complete neuropsychological assessment due to sensory or communication impairment (e.g., severe vision loss, hearing impairment, language barrier, aphasia)

Sponsors & Collaborators

• New Hospitals Georgia: lead

Study Sites (1)

New Hospitals

Tbilisi, 0162, Georgia

RECRUITING

Related Publications (1)

• Darsalia T, Evered L, Macharadze T. Preoperative frailty and postoperative neurocognitive disorders in older adults in Georgia: study protocol for a prospective, observational cohort study. BMJ Open. 2025 Oct 20;15(10):e101245. doi: 10.1136/bmjopen-2025-101245.

  PMID: 41120173 DERIVED

MeSH Terms

Conditions

Frailty; Delirium; Dementia

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• Tamar Macharadze, Dr

  David Tvildiani Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tamar Macharadze, Dr

CONTACT

004917665798734; tamar.macharadze@dtmu.edu.ge

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator Dr.Tamar Macharadze

Study Record Dates

• First Submitted: November 1, 2024
• First Posted: November 21, 2024
• Study Start: April 26, 2023
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: August 29, 2025

Record last verified: 2024-11

Locations

GE (1)