Tanta University
Tanta, El-Gharbia, 31527, Egypt
NCT Number: NCT06242275
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.
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Notify Me65 year and older
All sexes
Observational
Tanta, El-Gharbia, 31527, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3rd day postoperatively
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.
Time frame: first 5 days after surgery
Incidence of postoperative delirium will be measured.
Time frame: 24 hours postoperatively
Correlation of salivary alpha-amylase with C-reactive protein will be assessed.
Time frame: 24 hours postoperatively
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.
Time frame: 24 hours postoperatively
Correlation of salivary alpha-amylase with morphine consumption will be assessed.
Tanta University
Other
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