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Perioperative Biomarkers and Postoperative Delirium in Older Adults Undergoing Abdominal Cancer Surgery

Recruitingn/aAges 65 Years - anyAllFatma Cigdem Ozakin
NCT07859488 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective observational cohort study aims to investigate the relationship between perioperative endogenous melatonin levels and postoperative delirium in patients aged 65 years or older undergoing elective abdominal cancer surgery. The study will also evaluate serotonin, kynurenine, kynurenic acid, and vitamin B12 as potential biomarkers associated with postoperative delirium. Participants will undergo routine standardized general anesthesia and thoracic epidural analgesia. Venous blood samples will be obtained preoperatively and on postoperative day 3. In participants who develop delirium, an additional blood sample will be obtained as soon as possible after delirium is detected. Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) on postoperative days 1, 3, and 5. No experimental drug or additional therapeutic intervention will be administered as

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📋 Eligibility rules (as published)
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.
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What it tests

  • Perioperative Biomarker Assessment
  • Confusion Assessment Method (CAM)
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Where

1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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