Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery
NCT ID: NCT06242275
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2024-02-10
2025-06-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Postoperative delirium (POD) group
Patients who will develop postoperative delirium
Salivary Alpha-amylase
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.
No Postoperative delirium (POD) group
Patients who will not develop postoperative delirium
Salivary Alpha-amylase
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.
Interventions
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Salivary Alpha-amylase
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.
Eligibility Criteria
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Inclusion Criteria
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status III.
* Undergoing lower extremity vascular surgery under general anesthesia.
Exclusion Criteria
* Inability to communicate.
* History of psychiatric diseases or previous stroke
* Previous history of pod.
* Those with smoking and drinking habits.
* Pregnant female.
65 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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ِAhmed Mohamed Ibrahim
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine
Locations
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Tanta University
Tanta, El-Gharbia, Egypt
Countries
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Other Identifiers
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36264PR462/12/23
Identifier Type: -
Identifier Source: org_study_id
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