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Completed

NCT Number: NCT06242275

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salivary Alpha-amylase

Diagnostic Test

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.

Primary outcomes

  1. The accuracy of salivary alpha-amylase as a predictor of postoperative delirium

    Time frame: 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 outcomes

  1. Incidence of postoperative delirium

    Time frame: first 5 days after surgery

    Incidence of postoperative delirium will be measured.

  2. Correlation of salivary alpha-amylase with C-reactive protein

    Time frame: 24 hours postoperatively

    Correlation of salivary alpha-amylase with C-reactive protein will be assessed.

  3. Correlation of salivary alpha-amylase with average pain score

    Time frame: 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.

  4. Correlation of salivary alpha-amylase with morphine consumption

    Time frame: 24 hours postoperatively

    Correlation of salivary alpha-amylase with morphine consumption will be assessed.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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