Clinical trial NCT06242275: Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery
Official title: Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Salivary Alpha-amylase
Delirium
Lower Extremity
Vascular Bypass Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 patients aged ≥ 65 years, both sexes, American Society of Anesthesiologists (ASA) physical status III, undergoing lower extremity vascular surgery under general anesthesia.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The accuracy of salivary alpha-amylase as a predictor of postoperative delirium
timeFrame: 3rd day postoperatively
Secondary outcomes:
measure: Incidence of postoperative delirium
timeFrame: first 5 days after surgery
measure: Correlation of salivary alpha-amylase with C-reactive protein
timeFrame: 24 hours postoperatively
measure: Correlation of salivary alpha-amylase with average pain score
timeFrame: 24 hours postoperatively
measure: Correlation of salivary alpha-amylase with morphine consumption
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References: