Perioperative Melatonin and Other Neuroinflammatory Biomarkers for Predicting Postoperative Delirium in Older Adults Undergoing Elective Abdominal Cancer Surgery
Sponsor study identifier
observational
100
1 country
1
Study Start
September 1, 2026
Actual (reported)Primary Completion
September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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 part of the study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2026
Actual (reported)September 30, 2026
Actual (reported)October 5, 2026
Actual (reported)September 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Serum Melatonin Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status
Serum melatonin concentration will be measured preoperatively and on postoperative day 3. For each participant, the change in melatonin concentration will be calculated as the postoperative day 3 value minus the preoperative value and reported in pg/mL. Participants will be classified as having postoperative delirium if at least one CAM assessment on postoperative days 1, 3, or 5 is positive. The change in melatonin concentration will be compared between participants with and without postoperative delirium.
Preoperative baseline to postoperative day 3; postoperative delirium status assessed through postoperative day 5
Number of Participants With Postoperative Delirium Assessed by the Confusion Assessment Method
Postoperative delirium will be assessed using the Confusion Assessment Method (CAM) on postoperative days 1, 3, and 5. A participant will be classified as having postoperative delirium if any of these postoperative CAM assessments is positive. According to the CAM algorithm, delirium is present when acute onset and fluctuating course and inattention are present together with either disorganized thinking or an altered level of consciousness. The number and percentage of participants with postoperative delirium will be reported.
Patients aged 65 years or older undergoing elective abdominal surgery for malignancy under general anesthesia with thoracic epidural analgesia. All participants will be prospectively followed for postoperative delirium through postoperative day 5. Participants will not be assigned to treatment groups. For analysis, participants will be classified according to whether postoperative delirium develops based on CAM assessments.
Venous blood samples will be obtained preoperatively and on postoperative day 3 for measurement of melatonin, serotonin, kynurenine, kynurenic acid, and vitamin B12. In participants who develop postoperative delirium, an additional blood sample will be obtained as soon as possible after delirium is detected. Biomarker measurements will not be used to determine clinical treatment.
The study population will consist of patients aged 65 years or older who are scheduled for elective abdominal surgery for malignancy at Bakirkoy Dr. Sadi Konuk Research and Training Hospital and who meet the study eligibility criteria and provide written informed consent.
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34147, Turkey (Türkiye)
Elbakry AA, El-Desoky IM, Saafan AG, Elsersy HE. The impact of melatonin on postoperative delirium in geriatric patients after colorectal surgery: a randomized placebo-controlled trial. Minerva Anestesiol. 2024 Jun;90(6):509-519. doi: 10.23736/S0375-9393.24.17888-1.
Phing AH, Makpol S, Nasaruddin ML, Wan Zaidi WA, Ahmad NS, Embong H. Altered Tryptophan-Kynurenine Pathway in Delirium: A Review of the Current Literature. Int J Mol Sci. 2023 Mar 15;24(6):5580. doi: 10.3390/ijms24065580.
Fatma Çiğdem Özakın, MD
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
First Submitted
September 30, 2026
First Posted
October 5, 2026
Study Start
September 1, 2026
Actual (reported)Primary Completion
September 1, 2027
EstimatedPostoperative day 1 through postoperative day 5
Change in Serum Serotonin Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status
Preoperative baseline to postoperative day 3
Change in Serum Kynurenine Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status
Preoperative baseline to postoperative day 3
Change in Serum Kynurenic Acid Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status
Preoperative baseline to postoperative day 3
The Confusion Assessment Method will be used to assess delirium preoperatively and on postoperative days 1, 3, and 5. Postoperative delirium will be considered present if at least one postoperative CAM assessment is positive.
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Inouye SK, Westendorp RG, Saczynski JS. Delirium in elderly people. Lancet. 2014 Mar 8;383(9920):911-22. doi: 10.1016/S0140-6736(13)60688-1. Epub 2013 Aug 28.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 6, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 5, 2026
Record last verified: 2026-09
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