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Postoperative cognitive dysfunction 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, but in some cases may be permanent.
The aetiology is multifactorial. One risk factor for developing POCD is the occurrence of postoperative delirium.
A total of 638 consecutive patients will be enrolled in the study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The cognitive function will be tested and compared to tests done before surgery. Postoperatively (from the day of operation until the 7th day and except of day 6) the grade of sedation; agitation; signs of delirium; pain; cardiac; respiratory; renal and infectious complications will be recorded.
As possible influencing factors, the investigators will document diagnosed depression; comorbidities; intraoperative blood loss; length of hospital stay; 1-year-mortality; number of operations/anaesthetics undergone after the initial operation.
Parameters that could trigger either depressive symptoms, neurocognitive dysfunction, anxiety, fatigue or lack of concentration will be recorded. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate, cortisone therapy and adrenal cortical insufficiency.
The methods include a neuropsychological test battery: TAP 2.3 (attention), Trail Making Test (TMT )A+B (attention), Digit span (memory), (Visual Learning and Memory Test (VLMT) (memory), Regensburgerwortfluessigkeitstest/fluency (RWT) subtests (executive function), Mehrfach-Wortschatz-Intelligenztest/vocabulary (MWT-B) (premorbid IQ).
Other measures are Hospital Anxiety and Depression Scale (HADS-D) (depressive symptoms and anxiety), Mini Mental State Examination (MMSE) 2 (dementia), Confusion Assessment Method (CAM-ICU) (delirium), Richmond Agitation and Sedation Scale (RASS) (sedation and agitation), Numeric Rating Scale (NRS) (pain) and Short Form Health Survey (SF-12) (health related quality of life).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| monitoring and non-medical prophylaxis of delirium | Other | The treatment group will receive monitoring and prophylaxis of delirium. The study arm designed to prevent delirium incorporates reorientation (watches, calendar, family photos, use of hearing aids, glasses and dentures, cognitive stimulation (newspaper, magazines, radio, television), early mobilisation, early enteral nutrition, early removal of drains or catheters, normalizing sleep-awake-rhythm. |
|
| Standard | No Intervention | The standard group will receive standard monitoring and standard treatment. The indication, choice and dosage of the medication used to treat delirium will be at the discretion of the ward doctor and will not be influenced by this study. The chosen medication as well as its dosage will be documented. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monitoring and non-medical prophylaxis of delirium | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative cognitive deficit (POCD) | measured by neuropsychological test battery, analysis | change from baseline in cognitive function at day 7, 3 months and 1 year after operation |
| Measure | Description | Time Frame |
|---|---|---|
| incidence and severity of postoperative delirium | measured 3 times per day via CAM-ICU | from the day of operation until the 7th postoperative day |
| number of patients with cardiac complications |
| Measure | Description | Time Frame |
|---|---|---|
| anxiety and depressive symptoms on HADS-D | The Hospital Anxiety and Depression Scale (HADS-D) is used to measure depressive symptoms. The 7 items are answered on a 4-point scale from 0 to 3 with a scale score varying between 0 and 21 (0-7 = normal, 8-10 = borderline, 11-14 = severe depressive symptoms, >15 very severe depressive symptoms). | 7 days, 3 months, 1 year after operation |
Inclusion Criteria:
Exclusion Criteria:
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| 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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daily documentation of cardiac complications (central venous oxygen saturation, myocardial infarction, acute heart failure, others)
| day of operation until 7th postoperative day |
| length of hospital stay | from day of admission until day of discharge, up to 24 weeks |
| mortality | 1 year |
| health related quality of life | Short Form Health Survey (SF-12) | 3 months, 1 year after operation |
| number of patients with respiratory complications | daily documentation of pulmonary complications (pneumonia, pulmonary oedema, others), | day of operation until 7th postoperative day |
| number of patients with renal complications | daily documentation of renal complications (creatinine, haemo(dia)filtration or haemodialysis) | day of operation until 7th postoperative day |
| number of patients with complications in the immunosystem | daily documentation of parameters mirroring the immune answer (C-reactive protein, leukocytes, procalcitonin) | day of operation until 7th postoperative day |
| postoperative pain scores on the numeric rating scale (NRS) | scale | day of operation until 7th postoperative day, 3 months, 1 year after operation |
| haemoglobin (Anaemia) on a score | Score Hb < 6 g/dl, 6-7.99 g/dl, 8-9.99 g/dl, > 9.99 g/dl | intraoperative |
| blood loss | estimated blood loss in milliliter | intraoperative |
| ID | Term |
|---|---|
| D000079690 | Postoperative Cognitive Complications |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| 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 |
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