Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery
- Conditions
- DeliriumLower ExtremitySalivary Alpha-amylaseVascular Bypass Surgery
- Interventions
- Diagnostic Test: Salivary Alpha-amylase
- Registration Number
- NCT06242275
- Lead Sponsor
- Tanta University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age ≥ 65 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status III.
- Undergoing lower extremity vascular surgery under general anesthesia.
- Patients who used any medication that could affect salivary glands (such as antihypertensive, antidepressants or antipsychotic drugs).
- Inability to communicate.
- History of psychiatric diseases or previous stroke
- Previous history of pod.
- Those with smoking and drinking habits.
- Pregnant female.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No Postoperative delirium (POD) group Salivary Alpha-amylase Patients who will not develop postoperative delirium Postoperative delirium (POD) group Salivary Alpha-amylase Patients who will develop postoperative delirium
- Primary Outcome Measures
Name Time Method The accuracy of salivary alpha-amylase as a predictor of postoperative delirium 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.
- Secondary Outcome Measures
Name Time Method Incidence of postoperative delirium first 5 days after surgery Incidence of postoperative delirium will be measured.
Correlation of salivary alpha-amylase with C-reactive protein 24 hours postoperatively Correlation of salivary alpha-amylase with C-reactive protein will be assessed.
Correlation of salivary alpha-amylase with average pain score 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.
Correlation of salivary alpha-amylase with morphine consumption 24 hours postoperatively Correlation of salivary alpha-amylase with morphine consumption will be assessed.
Trial Locations
- Locations (1)
Tanta University
🇪🇬Tanta, El-Gharbia, Egypt