Perioperative Biomarkers and Postoperative Delirium in Older Adults Undergoing Abdominal Cancer Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorFatma Cigdem Ozakin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Perioperative Biomarker Assessment
Diagnostic testVenous 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.
Confusion Assessment Method (CAM)
Diagnostic testThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Older Adults Undergoing Elective Abdominal Cancer Surgery2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Preoperative baseline to postoperative day 3; postoperative delirium status assessed through postoperative day 52
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.
Time frame
Postoperative day 1 through postoperative day 5Secondary outcomes
1
Change in Serum Serotonin Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status
Serum serotonin concentration will be measured preoperatively and on postoperative day 3. The change from the preoperative value will be calculated for each participant and compared between participants with and without postoperative delirium.
Time frame
Preoperative baseline to postoperative day 32
Change in Serum Kynurenine Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status
Serum kynurenine concentration will be measured preoperatively and on postoperative day 3. The change from the preoperative value will be calculated for each participant and compared between participants with and without postoperative delirium.
Time frame
Preoperative baseline to postoperative day 33
Change in Serum Kynurenic Acid Concentration From Preoperative Baseline to Postoperative Day 3 According to Postoperative Delirium Status
Serum kynurenic acid concentration will be measured preoperatively and on postoperative day 3. The change from the preoperative value will be calculated for each participant and compared between participants with and without postoperative delirium.
Time frame
Preoperative baseline to postoperative day 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fatma Cigdem Ozakin
Lead sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor institution
Source ClinicalTrials.gov