Study of Depressive Symptoms Predicting Postoperative Cognitive Dysfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Are Preoperative Depressive Symptoms Predictive for Postoperative Dysfunction in Non-cardiac Surgery?

Conditions
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Postoperative Cognitive Dysfunction, Postoperative Delirium, Depressive Symptoms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients and healthy controls: Age > 60 years Written informed patient's consent Additional Inclusion Criteria for patients: Elective non-cardiac surgery and non-neurosurgical procedures in general anaesthesia or combined general/regional anaesthesia Minimum of duration of operation 120 minutes Baseline testing 3-14 days preoperatively Additional Inclusion Criteria for healthy controls: matched for age, gender and education no surgery over the study period Exclusion Criteria for patients and healthy control: German not mother tongue Illiteracy Mental disability Vision impairment not correctable Hearing impairment not correctable Illegal substance abuse (current or past history) Alcohol abuse (current or past history) Chronic benzodiazepine use Psychosis (current or past history) Parkinson Disease Dementia Multiple sclerosis Epilepsy (current or past history) Cerebral tumor (current or past history) Apoplexy or intracranial bleeding (current or past history) Severe traumatic brain injury (current or past history) Severe liver disease (Child Pugh B, C, liver insufficiency) Severe kidney disease with dialysis Mini Mental Status Examination < 24 points

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| elective non-cardiac surgery and non-neurosurgical procedures<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 |