Delirium, Lower Extremity, Salivary Alpha-amylase, Vascular Bypass Surgery
Conditions
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.
Interventions
DIAGNOSTIC_TESTSalivary 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.
Sponsors
Tanta University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 65 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status III. * Undergoing lower extremity vascular surgery under general anesthesia.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Egypt
Outcome results
None listed