NCT06700291 Preoperative Frailty and Postoperative Neurocognitive Disorders in Geriatric Patients in Georgia
| NCT ID | NCT06700291 |
| Status | Recruiting |
| Phase | — |
| Sponsor | New Hospitals Georgia |
| Condition | Frailty |
| Study Type | OBSERVATIONAL |
| Enrollment | 230 participants |
| Start Date | 2023-04-26 |
| Primary Completion | 2026-04-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 230 participants in total. It began in 2023-04-26 with a primary completion date of 2026-04-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Contact & Investigator
Tamar Macharadze, Dr
PRINCIPAL INVESTIGATOR
David Tvildiani Medical University
Frequently Asked Questions
Who can join the NCT06700291 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06700291 currently recruiting?
Yes, NCT06700291 is actively recruiting participants. Contact the research team at tamar.macharadze@dtmu.edu.ge for enrollment information.
Where is the NCT06700291 trial being conducted?
This trial is being conducted at Tbilisi, Georgia.
Who is sponsoring the NCT06700291 clinical trial?
NCT06700291 is sponsored by New Hospitals Georgia. The principal investigator is Tamar Macharadze, Dr at David Tvildiani Medical University. The trial plans to enroll 230 participants.