Postoperative Cognitive Dysfunction, Postoperative Delirium, Frailty
Conditions
Keywords
postoperative cognitive dysfunction, frailty, S 100β, NSE, IL-6, HMGB-1 protein, NIRS, geriatric anesthesia
Brief summary
Postoperative cognitive changes are more common in elderly patients, which can result in poor quality of life, loss of workforce, disability, early retirement, physical-social dependence, increased health care cost and premature mortality. Postoperative cognitive complications are also quite common in extensive oncological surgeries. In this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (POCD) in geriatric urologic oncology patients with brain injury and inflammatory markers \[S100 β, neuron specific enolase (NSE), interleukin 6 (IL-6) and high mobility group box-1 (HMGB-1 protein)\].
Detailed description
The incidence of POCD changes by age group, type of surgery, testing neuropsychological tests, timing of tests, and the method used for diagnosis. In non-cardiac surgery over the age of 60; the incidence of POCD was 26% in the postoperative 1st week and 10% in the postoperative 3rd month. Although old age is an important risk factor, POCD incidence of up to 36.6% has been reported in a younger period. Major cancer surgery is an important risk factor for development of POCD. Numerous biomarkers such as; S100β, NSE, Human IL-6, HMGB-1 protein; have been evaluated in studies to determine the diagnosis, prognosis, stage and treatment of POCD. In this study, our aim is to evaluate the relationship between the development of postoperative cognitive dysfunction (POCD) in geriatric urologic oncology patients with brain injury and inflammatory markers. (S100β, NSE, Human IL-6 and HMGB-1 protein).The hypothesis of our study is that postoperative brain injury and inflammatory markers (S100β, NSE, Human IL-6 and HMGB-1 protein) will be higher in patients who develop POCD compared to patients who do not develop POCD in geriatric urologic oncology surgery.
Interventions
Patients are monitored by near infrared spectroscopy before anesthesia induction until end of the operation. Graphical presentation of cerebral oxygenation during surgery evaluated by INVOS Analytics Tool Version 1.2.
DIAGNOSTIC_TESTBlood sample
Blood samples are obtained before and after surgery. S-100, Neuron specific enolase (NSE), Interleukin-6 (IL-6), High Mobility Group Box Protein (HMGB-1) are going to be studied by ELISA method after data collection process end.
DIAGNOSTIC_TESTAddenbrooke Cognitive Examination III (ACE-III)
ACE-III is administered to study participants one day before surgery, 1 week after surgery, and three months after surgery to diagnose postoperative cognitive dysfunction.
DIAGNOSTIC_TESTConfusion Assessment Method
Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.
Sponsors
Istanbul University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over the age of 65 who are planned to undergo major urooncological surgery.
Exclusion criteria
* Patients who refuse to participate in the study. * Patients with severe hearing-vision problems. * Patients with serious neurological-psychiatric disorders. * Patients with language barrier. * Patients with missing in any interventions. * Patients with blood samples that are not suitable for the ELISA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukine-6 (IL-6) (pg/mL) | Change from baseline serum concentration of IL-6 at 6 hours | Blood IL-6 concentration is determined by an enzyme-linked immunosorbent assay kit. |
| S 100β (pg/mL) | Change from baseline serum concentration of S 100 β at 6 hours | Blood S 100β concentration is determined by an enzyme-linked immunosorbent assay kit. |
| High Mobility Group Box1 Protein (HMGB1) (ng/mL) | Change from baseline serum concentration of HMGB1 at 6 hours | HMGB1 concentration is determined by an enzyme-linked immunosorbent assay kit. |
| Human Neuron Specific Enolase (h-NSE) (ng/mL) | Change from baseline serum concentration of h-NSE at 6 hours | h-NSE concentration is determined by an enzyme-linked immunosorbent assay kit. |
| Addenbrooke cognitive examination at the day before surgery. | The day before surgery. | Test score is between 0-100. 100 is the best point and 0 is the worst point in the test. The test has five cognitive domains including attention, memory, language, visuospatial function, and verbal fluency. Patients who score less than 88 in preoperative tests will be diagnosed with mild cognitive impairment. |
| Addenbrooke cognitive examination at seventh day after surgery. | The seventh day after surgery. | POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores. |
| Addenbrooke cognitive examination at third months after surgery. | The third months after surgery. | POCD is diagnosed by 1 standard deviation decrease from the preoperative test scores. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral oxygenation | During surgery | Cerebral hypoxia is defined as reduction of regional oxygen saturation by 10 % from baseline before surgery. |
| Overall postoperative complications | Up to postoperative three months. | Stroke, transient ischemic attack, arrhythmia, heart failure, myocardial injury, respiratory failure, pneumonia, ileus, acute kidney injury, prolonged length of stay, mortality. |
| Postoperative delirium | Up to postoperative day one | Postoperative delirium is diagnosed by confusion assessment method. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactEmre Şentürk, MD
Outcome results
None listed