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

NCT06242275 | Completed

• 1 other identifier: 36264PR462/12/23
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Salivary Alpha-amylase; Delirium; Lower Extremity; Vascular Bypass Surgery

Outcome Measures

Primary Outcomes (1)

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

  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.

  3rd day postoperatively

Secondary Outcomes (4)

• Incidence of postoperative delirium

  first 5 days after surgery

• Correlation of salivary alpha-amylase with C-reactive protein

  24 hours postoperatively

• Correlation of salivary alpha-amylase with average pain score

  24 hours postoperatively

• Correlation of salivary alpha-amylase with morphine consumption

  24 hours postoperatively

Study Arms (2)

Postoperative delirium (POD) group

Patients who will develop postoperative delirium

Diagnostic Test: Salivary Alpha-amylase

No Postoperative delirium (POD) group

Patients who will not develop postoperative delirium

Diagnostic Test: Salivary Alpha-amylase

Interventions

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.

No Postoperative delirium (POD) group; Postoperative delirium (POD) group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status III.
• Undergoing lower extremity vascular surgery under general anesthesia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 5, 2024
• Study Start: February 10, 2024
• Primary Completion: June 17, 2025
• Study Completion: June 19, 2025
• Last Updated: June 25, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)