Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery

Last updated: January 18, 2025
Sponsor: Tanta University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dementia

Treatment

Salivary Alpha-amylase

Clinical Study ID

NCT06242275
36264PR462/12/23
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 65 years.

  • Both sexes.

  • American Society of Anesthesiologists (ASA) physical status III.

  • Undergoing lower extremity vascular surgery under general anesthesia.

Exclusion

Exclusion Criteria:

  • Patients who used any medication that could affect salivary glands (such asantihypertensive, 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

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: Salivary Alpha-amylase
Phase:
Study Start date:
February 10, 2024
Estimated Completion Date:
April 12, 2025

Study 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.

Connect with a study center

  • Tanta University

    Tanta, El-Gharbia 31527
    Egypt

    Active - Recruiting

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