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Postoperative cognitive dysfunction (POCD) describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months. In some cases, changes are permanent.
The aetiology of POCD is multifactorial. One described risk factor is preoperative existing depressive symptoms in patients undergoing cardiac surgery.
A total of 300 consecutive patients and 80 healthy controls will be enrolled in this study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The co gnitive function will be tested and compared to tests done before surgery. Postoperatively - from the day of operation until the 7th day (except day 6) - grade of sedation, agitation, signs of delirium, pain, cardiac, respiratory, renal and infectious complications will be monitored.
Next to preoperative depressive symptoms we will also evaluate a diagnosed depression, anxiety, pain, health-related quality of life, physical comorbidities, adrenal cortical insufficiency, type of anaesthesia, intraoperative blood loss, organ complications, postoperative delirium, baseline cognitive functioning and the number of operations/anaesthetics in the study period after the initial operation as further potential predictors of POCD.
In addition, laboratory values and certain medications will be documented. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate and cortisone therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| elective non-cardiac surgery and non-neurosurgical procedures | 300 Patients aged 60 years and older undergoing elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia with a duration of operation of 120 minutes or longer. 80 age-, gender- and education-matched healthy controls. |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of occurrence of early POCD | POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function) | 7 days |
| Frequency of occurrence of intermediate POCD | POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function) | 3 months |
| Frequency of occurrence of late POCD | POCD is measured by use of a neuropsychological test battery comprising the following subtests: Alertness, Go/Nogo, and Incompatibility from the TAP 2.3 (attention), Trail Making Test A and B (attention), Digit span (memory), Verbal Learning and Memory Test (memory), Regensburg Word Fluency Test (executive function) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of occurrence of postoperative delirium | measured twice per day: Confusion Assessment Method (CAM-ICU) and Richmond Agitation and Sedation Scale (RASS) | 7th postoperative day |
| Rate of organ complications (cardiac, respiratory, renal) |
| Measure | Description | Time Frame |
|---|---|---|
| Dementia | Change from baseline sum score on the Mini-Mental State Examination (2nd ed.) [Time Frame: Before operation to 7 days, 3 months and 1 year after operation]. | |
| Preoperative depressive symptoms and anxiety | Preoperative depressive symptoms and anxiety are assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS comprises 14 Items and 2 subscales with 7 items each. The items are answered on a 4-point rating scale from 0 to 3 with a scale score varying between 0 and 21. Higher scores represent higher distress (cut-off- scores: 0-7 = normal, 8-10 = borderline, 11-14 = severe symptoms, >=15 = very severe symptoms). |
Inclusion Criteria for patients and healthy controls:
Additional Inclusion Criteria for patients:
Additional Inclusion Criteria for healthy controls:
Exclusion Criteria for patients and healthy control:
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Female and male patients, aged 60 years and older undergoing elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia. To correct for practice effects and conduct additional comparisons, 80 healthy controls will be enrolled and assessed at the same time points (neuropsychological tests and questionnaires).
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| Name | Affiliation | Role |
|---|---|---|
| Julia Wiede, MD | Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Intensive Care Medicine, University Hospital Hamburg Eppendorf, Univ.-Prof. Dr. med. Alwin E. Goetz and Prof. Dr. med. Christian Zoellner | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D000071257 | Emergence Delirium |
| D003863 | Depression |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
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| day of operation until 7th postoperative day |
| Hospital length of stay | day of admission until day of discharge, up to 24 weeks |
| Mortality | 1 year |
| Health related quality of life | Time Frame: 7 days after operation [Measure: Short Form-12 Health Survey: Item General Health] Time Frame: 3 months after operation [Measure: Short Form-12 Health Survey: Physical and mental health summary measures] Time Frame: 1 year after operation [Measure: Short Form-12 Health Survey: Physical and mental health summary measures] | 7 days, 3 months, 1 year after operation |
| Baseline |
| Past or present diagnosed depression | A self-administered questionnaire was developed to explore pre-existing depression (current or in past medical history) and its medical or/and non-medical treatment. | Baseline |
| Pre- and perioperative pain | Preoperative pain: Numerical Rating Scale from 0 to 10 [Time Frame: Baseline] Perioperative pain: Numerical Rating Scale from 0 to 10, averaged over one week [Time Frame: Interval from day of operation to day 7 after operation] | Baseline and interval from day of operation to day 7 after operation |
| Premorbid Intelligence | Multiple-Choice Vocabulary Intelligence Test (MWT-B, sum score) | Baseline |
| Preoperative cognitive functioning | Global mean z-score on the neuropsychological test battery | Baseline |
| Postoperative depressive symptoms and anxiety | HADS, depression scale score [Time Frame: 7 days and 3 months after operation] HADS, anxiety scale score [Time Frame: 7 days and 3 months after operation] | 7 days, 3 months |
| Change in depressive symptoms and anxiety from baseline to 1 year | Change from baseline scale scores on the HADS depression and anxiety subscales [Time Frame: Before operation to 7 days, 3 months and 1 year after operation]. |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |