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

T

Tanta University

Status

Completed

Conditions

Delirium
Vascular Bypass Surgery
Lower Extremity
Salivary Alpha-amylase

Treatments

Diagnostic Test: Salivary Alpha-amylase

Study type

Observational

Funder types

Other

Identifiers

NCT06242275
36264PR462/12/23

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Postoperative delirium (POD) group
Description:
Patients who will develop postoperative delirium
Treatment:
Diagnostic Test: Salivary Alpha-amylase
No Postoperative delirium (POD) group
Description:
Patients who will not develop postoperative delirium
Treatment:
Diagnostic Test: Salivary Alpha-amylase

Trial contacts and locations

1

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Central trial contact

Ahmed M Ibrahim, MD

Data sourced from clinicaltrials.gov

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