Clinical trial NCT05419596: The Analysis of Gene Variants Related to POCD in Elderly Patients
Official title: The Analysis of Gene Variants Related to POCD in Elderly Patients: a Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Dysfunction
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 126
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are over 60 years old and scheduled for elective/semielective major urologic surgery

Brief summary: The pathophysiology of postoperative cognitive dysfunction (POCD) following surgery may be related to Alzheimer's disease. Different studies show that; low levels of glial cell line-derived growth factor are found in both POCD and Alzheimer, and brain cholinergic markers like Choline acetyl transferase activity, High affinity choline uptake activity, and Acetil Choline (Ach) activity are decreased in Alzheimer disease.We know cholinergic inputs in the basal forebrain have a critical role in many other functions including memory, attention, arousal and sensory processing.

Cholinergic neuron located basal section of forebrain degenerate extensively in Alzheimer disease which shares similarities with postoperative delirium and POCD. Ach binds to two well-known receptors in brain that are Nicotinic receptors which implicate several important functions such as "memory, learning, arousal and reward" and Muscarinic receptors which are widely distributed in forebrain and play an important role of development delirium and POCD. Dysfunction of cholinergic system may be one key aspect of postoperative DELIRIUM, POCD and ALZHEIMER disease.

In this investigation; we would like to evaluate the relationship between genes encoding inflammation-related mediators detected in postoperative cognitive dysfunction and gene variants in Alzheimer's disease in a larger panel for elder patients undergoing major urologic surgery. Therefore our study will focus on demographic information of the patients (age, gender, comorbidity), neurocognitive tests (1 week before the surgery, postoperative 1st week and postoperative 3rd month), intraoperative data (mean arterial pressure, heart rate, need for inotrope, duration of mechanical ventilation, need for transfusion), and biochemical tests (Preoperative and postoperative blood samples for each patient) which are APOE, phosphatidylinositol-binding clathrin assembly protein, CR1 - complement receptor 1, ATP-binding cassette transporter, IL6, TREM.


Eligibility criteria: Inclusion Criteria:

* Patients over age of 60 years
* Patients scheduled for major urologic surgery

Exclusion Criteria:

* Failure of the patient or the person with legal authority to make a decision about him/her.
* Patients with severe hearing-vision problems before surgery.
* Patients with severe neurological-psychiatric disorders before surgery.
* Patients who cannot find a common language.
* Emergency surgeries

Primary outcomes:
measure: Change in Interleukin-6 levels in elder atients undergoing major urologic surgery
timeFrame: From preoperative 1 hour to postoperative 2 hours
Secondary outcomes:
measure: Addenbrooke cognitive examinations change (Preoperative to postoperative)
timeFrame: Up to Postoperative 7 days.
measure: Addenbrooke cognitive examinations change for the chronic period
timeFrame: Up to postoperative three months
measure: The difference in IL-6 between the groups
timeFrame: Up to postoperative 1 hour
measure: DNA sequence analysis of APOE gene
timeFrame: Up to postoperative 1 hour
measure: DNA sequence analaysis of phospatydil-inositol binding clathrin gene
timeFrame: Up to postoperative 1 hour
measure: DNA sequence analysis of complement receptor 1 protein gene
timeFrame: Up to postoperative 1 hour
measure: DNA sequence analysis of Triggering receptor expressed on myeloid cells2 (TREM2)
timeFrame: Up to postoperative 1 hour
measure: DNA sequence analysis of ATP-binding cassette transporter gene
timeFrame: Up to postoperative 1 hour
Other outcomes:
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