Cerebral Regional Oxygen Saturation and Markers of Brain Damage During Primary Hip Arthroplasty

Study Overview
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Brief Summary
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Postoperative Cognitive Disorders (POCD) are common in hospitalized people > 60 year old, especially in orthopedic patients. Etiology of POCD is complex, and in some aspects still remains unclear. The role of thromboembolic events in etiology of POCD was discussed. The incidence of such events in patients who underwent big joints arthroplasty can be as high as 40 to 60%, although some cases are subclinical. Thromboembolic material can block a blood flow through a vessels in the brain. As a consequence cerebral neurons can be damaged or destroyed. After neuronal damage specific substances, such as S100B protein, glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) are released to the blood. The serum concentrations of these biomarkers can be measured. Moreover, the block of blood flow will decrease regional cerebral saturation in affected parts of the brain. In this project the authors would like to analyze the correlation between the regional cerebral saturation and serum concentration of both S100B protein and GFAP in orthopedic patients scheduled to primary hip arthroplasty.

Official Title
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The Regional Cerebral Oxygen Saturation and Both S100B and GFAP Proteins Serum Concentration in Patients Undergoing Primary Hip Arthroplasty.

Conditions
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Delirium, Dementia, Amnestic, Cognitive Disorders, Arthroplasty, Hip Replacement

Intervention / Treatment
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* Device: cemented or cementless type of hip prothesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient scheduled to primary hip arthroplasty, orthopedic procedure under spinal anesthesia. Exclusion Criteria: patients younger than 18 y.o., surgery under general anesthesia, patients who refused to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cemented<br>Primary hip arthroplasty with bone cement use. | Device: cemented or cementless type of hip prothesis<br> <br> |
| Other: cementless<br>Primary hip arthroplasty without bone cement use. | Device: cemented or cementless type of hip prothesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in regional cerebral oxygen during primary hip arthroplasty | The analysis of regional cerebral oxygen saturation will start just before the anesthesia and ends just after the surgery. | Duration of the orthopedic procedure, an expected average of 2 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum levels of S100B protein from baseline at 72 hours after the surgery | The serum concentration of S100B protein will be measured [1] just before the surgery, [2] just after the end of the surgery, an expected average of two hours, [3] 6 hours after the beginning of the surgery, [4] 24 hours after the beginning of the surgery, and [5] 72 hours after the beginning of the surgery. | 72 hours | 
| Changes in serum levels of GFAP from baseline at 72 hours after the surgery | The serum concentration of GFAP protein will be measured [1] just before the surgery, [2] just after the end of the surgery, an expected average of two hours, [3] 6 hours after the beginning of the surgery, [4] 24 hours after the beginning of the surgery, and [5] 72 hours after the beginning of the surgery. | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biological Markers