Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-12 @ 10:43 AM
Study NCT ID:
NCT04225702
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2019-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect Of Aspirin Preoperative on Postoperative Cognitive Dysfunction In Elderly Patients Undergoing Knee Arthroplasty
Sponsor:
Xuzhou Medical University
Organization:
Study Overview
Official Title:
Effect Of Long-term Aspirin Preoperative on Postoperative Cognitive Dysfunction In Elderly Patients Undergoing Knee Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Studies have shown that the lifetime risk of developing symptomatic knee osteoarthritis is 40% in men and 47% in women; and the risk can be increased to 60% when the patient's BMI reaches 30 kg/m2. In this population, knee replacement is the most common, effective, and cost-effective method in all treatments with reducing pain, improving joint function and quality of life. Postoperative cognitive dysfunction (POCD) is a common complication in the elderly, and its incidence can reach 25-40% in major non-cardiac surgery. As for POCD can prolong hospital stay, increase mortality and morbidity, and increase social and economic burden, it is especially important for the prevention and treatment of POCD. However, The mechanism of POCD is still unclear. Studies suggest that it may involve inflammation and oxidative stress in the central nervous system. But for the elderly, they are in a state of low inflammatory response. At the same time, surgery and tourniquets also can trigger or aggravate inflammatory response. Once the inflammatory factors released into the blood circulation, they can act on the central nervous system in a variety of ways. As a result,elderly patients are more likely to develop POCD. In addition, some studies have shown that pain can also increase cognitive burden. Aspirin, its pharmacodynamic effects includes anti-inflammatory and analgesic effects which may have a certain effect on the prevention of POCD.
Detailed Description:
Elderly patients undergoing knee replacement are more likely to develop POCD. The aim of this study is to determine the incidence of short-term POCD and long-term cognitive status in the elderly patients who use Aspirin atleast three months before knee replacement.And then, the study evaluates the effect of Aspirin on the incidence of postoperative delirium. In addition, it also shows the risk factors for POCD such as postoperative delirium, pain, C reactive protein and so on in the elderly patients who undergo knee replacement.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: