Cognitive Impairment Following Elective Spine Surgery

Study Overview
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Brief Summary
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Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades. It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.

Official Title
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Kognitive Störungen Nach Elektiver Wirbelsäulenchirurgie Bei Älteren

Conditions
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Cognitive Impairment, Postoperative Delirium, Spine Fusion

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 60 years scheduled for elective spine surgery without opening the dura patient can give informed consent him-/herself German native speaker Exclusion Criteria: dementia or neurodegenerative disease psychiatric disease prescription of CNS-active medication (e.g. antidepressants, antipsychotics, sedatives, alpha-1-antagonists) impossible to participate in follow-up participation in an interventional trial electronic or displacable metallic implants active neoplasm

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 |
| --- | --- |
| Delirium<br> | |
| No Delirium<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative delirium - incidence | screening through Nu-DESC (Nursing Delirium Screening Scale) ≥ 2 and verification of screening procedure by DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) criteria once during each shift | ≤ 3 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative delirium - duration | screening through Nu-DESC ≥ 2 and verification of screening procedure by DSM-V criteria DSM-V once during each shift | ≤ 3 days postoperatively or until delirium resolves | 
| postoperative delirium - severity | rated through CAM-S (Confusion Assessment Method - Severity) if patient was identified to be delirious | ≤ 3 days postoperatively or until delirium resolves | 
| postoperative cognitive dysfunction - severity | CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease - Plus) | baseline and 3 months postoperatively | 
| pre- and postoperative intelligence | MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B) | baseline and 3 months postoperatively | 
| Markers of systemic inflammation | C-reactive protein, Interleukins, Tumor necrosis factor among others | ≤ 2 days postoperatively | 
| Markers of neuroinflammation | Glial fibrillary acidic protein among others | ≤ 2 days postoperatively | 
| Markers of oxidative and metabolic stress | Malondialdehyd | ≤ 2 days postoperatively | 
| Patient Reported Quality of life | PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating) | baseline and 3 months postoperatively | 
| Patient Reported Quality of life - 2 | SF-36 (Short Form 36) | baseline and 3 months postoperatively | 
| Anxiety and depression | HADS (Hospital Anxiety and Depression Scale) | baseline and 3 months postoperatively | 
| Frailty | Groningen Frailty Scale | baseline and 3 months postoperatively | 
| Structural magnetic resonance imaging | White matter lesions | baseline and 3 months postoperatively | 
| Functional magnetic resonance imaging | Resting state networks | baseline and 3 months postoperatively | 
| Cerebral vasculature | Ultrasound of extra- and intracranial cerebral arteries | baseline | 
| Genetic polymorphisms |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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delirium, postoperative cognitive dysfunction, spine surgery, elderly, neuroinflammation, magnetic resonance imaging, resting state fmri, cerebral vasculature, quality of life