Perioperative Biomarkers and Postoperative Delirium in Older Adults Undergoing Abdominal Cancer Surgery
Official title: Perioperative Melatonin and Other Neuroinflammatory Biomarkers for Predicting Postoperative Delirium in Older Adults Undergoing Elective Abdominal Cancer Surgery
Run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · NCT07859488 · Data updated 2026-11-12
This study will see if certain biomarkers like melatonin and serotonin can predict delirium in adults 65+ after abdominal cancer surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | September 1, 2027 |
| Study ends | September 6, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT07859488 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 65 years or older undergoing elective abdominal cancer surgery with ASA II or III, able to consent, and eligible for thoracic epidural analgesia.
✕Probably not a fit
Patients with preexisting major neurocognitive disorders or those not experiencing delirium would derive no direct benefit from the biomarker findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort study of adults aged 65 and older undergoing elective abdominal cancer surgery. Researchers will measure perioperative biomarkers—melatonin, serotonin, kynurenine, kynurenic acid, and vitamin B12—before surgery and on postoperative day 3, with an extra sample if delirium is detected. Postoperative delirium will be assessed on days 1, 3, and 5 using the CAM. No experimental treatments are given; the goal is to understand associations between biomarker levels and delirium risk under standard anesthesia and thoracic epidural analgesia. Additional perioperative data, including hemodynamics and cerebral oxygenation, will be collected to explore mechanisms and potential predictors.
Why it matters
Potential benefit: If successful, the findings could help identify biomarkers that predict delirium risk and inform future strategies to prevent delirium in high-risk patients.
How similar studies have gone: Previous research in related surgical populations has linked circadian and neurotransmitter biomarkers to delirium risk, but this specific perioperative biomarker panel in abdominal cancer surgery is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 65 years or older. * Scheduled for elective abdominal surgery for malignancy. * American Society of Anesthesiologists (ASA) physical status II or III. * Surgery planned under general anesthesia. * Eligible for thoracic epidural analgesia without contraindications to epidural catheter placement. * Provision of written informed consent. Exclusion Criteria: * Preoperative dementia, Alzheimer disease, Parkinson disease, other known neurodegenerative disease, or a history of preoperative cognitive impairment. * Emergency surgery. * Contraindication to epidural analgesia or refusal of epidural catheter placement. * Chronic use of corticosteroids, melatonin preparations, or medications affecting the serotonergic system, including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or tricyclic antidepressants. * Parenteral or high-dose oral vitamin B12 treatment within the previous 3 months. * Diagnosis of pernicious anemia. * Communication impairment preventing delirium assessment. * Advanced liver or kidney failure. * Intraoperative mean arterial pressure below 65 mmHg. * Surgical duration longer than 240 minutes. * Refusal to participate in the study.
Where it's running
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Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Fidan Aygün, MD
- Email: fidanaygun1971@gmail.com
- Phone: +90 505 400 2965
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.