Using salivary alpha-amylase to predict delirium after limb bypass surgery
Perioperative Salivary Alpha-amylase as a Predictor of Delirium After Lower Extremity Vascular Bypass Surgery
This study is testing if measuring a certain enzyme in saliva can help predict if older patients will experience confusion after having surgery on their legs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06242275 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the role of salivary alpha-amylase as a biomarker for predicting postoperative delirium (POD) in elderly patients undergoing lower extremity vascular bypass surgery. Delirium is a sudden neuropsychiatric condition that can occur after surgery, and the study investigates the biochemical parameters associated with neuroinflammation and cognitive regulation. By analyzing salivary alpha-amylase levels, researchers hope to identify a reliable predictor for POD, which could lead to better management strategies for at-risk patients.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients aged 65 and older who are undergoing lower extremity vascular surgery under general anesthesia.
Not a fit: Patients with a history of psychiatric diseases, previous strokes, or those taking medications that affect salivary glands may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to predict and potentially prevent delirium in elderly patients after surgery.
How similar studies have performed: While several biomarkers have been explored for predicting postoperative delirium, the specific use of salivary alpha-amylase as a predictor is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed M Ibrahim, MD
- Email: ahmed.edib@med.tanta.edu.eg
- Phone: 00201141779238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.