Erythropoietin for the Prevention of Postoperative Delirium in Elderly Patients Undergoing Total Joint Arthroplasty: Randomized Controlled Study
Overview
- Phase
- Phase 4
- Intervention
- Erythropoietin
- Conditions
- Postoperative Delirium
- Sponsor
- Yonsei University
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- Incidence of delirium
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Postoperative delirium is a common complication after surgery. The underlying pathophysiology of this complication is unclear, however neuroinflammation and oxidative stress secondary to surgery had shown to be the cause of postoperative cognitive dysfunction and delirium. Erythropoietin represents non-erythropoietic effects of anti-inflammatory properties. The aims of this study were to determine the role of erythropoietin toward the development of postoperative delirium, in terms of changes in inflammatory reaction by affecting the innate immunity in elderly patients undergoing total joint arthroplasty surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 65 years and older
- •Patients scheduled for elective total knee arthroplasty, total hip arthroplasty
Exclusion Criteria
- •Unable to communicate
- •Cognitive impairment
- •Unable to pre-screen delirium due to underlying central nervous system disease
- •History of hypersensitivity related to erythropoietin and other anesthesia-related drugs
- •History of myocardial infarction, pulmonary infarction, cerebral infarction, ischemic vascular disease, epilpesy, chronic liver disease, chronic kidney disease
- •Uncontrolled high blood pressure
- •Within one month of starting anti-hypertensive medication
Arms & Interventions
Erythropoietin
500 IU/kg of EPO given intramuscularly 3 times for each patient
Intervention: Erythropoietin
Control
Same amount of normal saline given intramuscularly 3 times for each patient
Intervention: normal saline
Outcomes
Primary Outcomes
Incidence of delirium
Time Frame: 2 days post surgery, 5 days post surgery
Development of postoperative delirium determined by validated evaluation tests.
Secondary Outcomes
- Inflammatory biomarker(before surgery, after surgery, 3 days post surgery day 3)