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The aim of this study is to evaluate the role of salivary Alpha-amylase as a predictor biomarker of POD in elderly patients undergoing limb bypass surgery.
Delirium is a neuropsychiatric syndrome that is characterized by the sudden onset of altered awareness, decreased ability to maintain attention, and disorders of the mental process. The pathophysiology of Postoperative delirium (POD) is related to postoperative neuroinflammation.
Biomarkers not only indicate a certain pathological state, but also provide information about disease activity and progression. Although several biomarkers are reported to predict POD, biomarkers with high sensitivity and specificity are still lacking.
Biochemical parameters associated with complement cascade (C3a, C3, C5a) and inflammatory response (IL-17A, IL-33, E-selectin, MMP9) were involved in neurocognitive regulation.
Salivary alpha amylase (SAA) enzyme is one of the most important enzyme compositions in the saliva that accounts for 40% to 50% of the total salivary proteins, and most of it is secreted from the parotid gland. SAA is locally produced by the highly differentiated epithelial acinar cells of the exocrine salivary glands, mostly of the parotid glands and plays an important role in carbohydrate hydrolysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative delirium (POD) group | Patients who will develop postoperative delirium |
| |
| No Postoperative delirium (POD) group | Patients who will not develop postoperative delirium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salivary Alpha-amylase | Diagnostic Test | Saliva samples will be obtained using a saliva collection system and salivary Alpha-amylase (SAA) level will be measured preoperatively, immediately postoperative, at the end of the 1st, 2nd, and 3rd postoperative days. For sampling, the swab will be placed into the patient's mouth for 2-5min by a specially trained nurse. A minimum of 0.2mL of saliva will be needed as per the manufacturer's recommendations to saturate the swab. |
| Measure | Description | Time Frame |
|---|---|---|
| The accuracy of salivary alpha-amylase as a predictor of postoperative delirium | The accuracy of salivary alpha-amylase will be measured by saliva samples which will be obtained using a saliva collection system and SAA level will be measured preoperatively, immediately postoperative, at the end of the 1st, 2nd, and 3rd postoperative days. | 3rd day postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | Incidence of postoperative delirium will be measured. | first 5 days after surgery |
| Correlation of salivary alpha-amylase with C-reactive protein | Correlation of salivary alpha-amylase with C-reactive protein will be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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60 patients aged ≥ 65 years, both sexes, American Society of Anesthesiologists (ASA) physical status III, undergoing lower extremity vascular surgery under general anesthesia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Tanta | El-Gharbia | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 24 hours postoperatively |
| Correlation of salivary alpha-amylase with average pain score | Correlation of salivary alpha-amylase with average pain score will be assessed. Pain score will be assessed using numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable. | 24 hours postoperatively |
| Correlation of salivary alpha-amylase with morphine consumption | Correlation of salivary alpha-amylase with morphine consumption will be assessed. | 24 hours postoperatively |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |