Cognitive Impairment, Postoperative Delirium, Spine Fusion
Conditions
Keywords
delirium, postoperative cognitive dysfunction, spine surgery, elderly, neuroinflammation, magnetic resonance imaging, resting state fmri, cerebral vasculature, quality of life
Brief summary
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.
Interventions
None listed
Sponsors
University Medicine Greifswald
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative delirium - incidence | ≤ 3 days postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative delirium - duration | ≤ 3 days postoperatively or until delirium resolves | screening through Nu-DESC ≥ 2 and verification of screening procedure by DSM-V criteria DSM-V once during each shift |
| postoperative delirium - severity | ≤ 3 days postoperatively or until delirium resolves | rated through CAM-S (Confusion Assessment Method - Severity) if patient was identified to be delirious |
| postoperative cognitive dysfunction - severity | baseline and 3 months postoperatively | CERAD-Plus (Consortium to Establish a Registry for Alzheimer's Disease - Plus) |
| pre- and postoperative intelligence | baseline and 3 months postoperatively | MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B) |
| Markers of systemic inflammation | ≤ 2 days postoperatively | C-reactive protein, Interleukins, Tumor necrosis factor among others |
| Markers of neuroinflammation | ≤ 2 days postoperatively | Glial fibrillary acidic protein among others |
| Markers of oxidative and metabolic stress | ≤ 2 days postoperatively | Malondialdehyd |
| Patient Reported Quality of life | baseline and 3 months postoperatively | PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating) |
| Patient Reported Quality of life - 2 | baseline and 3 months postoperatively | SF-36 (Short Form 36) |
| Anxiety and depression | baseline and 3 months postoperatively | HADS (Hospital Anxiety and Depression Scale) |
| Frailty | baseline and 3 months postoperatively | Groningen Frailty Scale |
| Structural magnetic resonance imaging | baseline and 3 months postoperatively | White matter lesions |
| Functional magnetic resonance imaging | baseline and 3 months postoperatively | Resting state networks |
| Cerebral vasculature | baseline | Ultrasound of extra- and intracranial cerebral arteries |
| Genetic polymorphisms | baseline | — |
Countries
Germany
Outcome results
None listed