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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06242275
• Other study ID #: 36264PR462/12/23
• Status: Not yet recruiting
• Start date: February 10, 2024
• Est. completion date: July 1, 2024

Study information

• Verified date: February 2024
• Source: Tanta University
• Contact: Ahmed M Ibrahim, MD
• Phone: 00201141779238
• Email: ahmed.edib[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Lower Extremity

Intervention

Diagnostic Test:
• Salivary Alpha-amylase
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. The samples will be then stored at -70°C until analysis.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of postoperative delirium	Incidence of postoperative delirium will be measured.	24 hours postoperatively
Secondary	Correlation of salivary alpha-amylase with C-reactive protein	Correlation of salivary alpha-amylase with C-reactive protein will be assessed.	24 hours postoperatively
Secondary	Correlation of salivary alpha-amylase with average pain score	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.	24 hours postoperatively
Secondary	Correlation of salivary alpha-amylase with morphine consumption	Correlation of salivary alpha-amylase with morphine consumption will be assessed.	24 hours postoperatively