Cognitive Impairment Following Elective Spine Surgery

Terminated

• Conditions: Postoperative Delirium; Spine Fusion; Cognitive Impairment

• Registration Number: NCT03486288
• Lead Sponsor: University Medicine Greifswald

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-06
• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-03
• Primary Completion: 2020-03-31
• Study Completion: 2021-03-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-26
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
pre- and postoperative intelligence	baseline and 3 months postoperatively	MWT-B (Mehrfachwahl-Wortschatz-Intelligenztest - B)
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
Patient Reported Quality of life	baseline and 3 months postoperatively	PROMIS-29 (Patient-Reported Outcomes Measurement Information System- Profile 29 incl. proxy-rating)
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)
Markers of systemic inflammation	≤ 2 days postoperatively	C-reactive protein, Interleukins, Tumor necrosis factor among others
Patient Reported Quality of life - 2	baseline and 3 months postoperatively	SF-36 (Short Form 36)
Markers of oxidative and metabolic stress	≤ 2 days postoperatively	Malondialdehyd
Structural magnetic resonance imaging	baseline and 3 months postoperatively	White matter lesions
Cerebral vasculature	baseline	Ultrasound of extra- and intracranial cerebral arteries
Markers of neuroinflammation	≤ 2 days postoperatively	Glial fibrillary acidic protein among others
Anxiety and depression	baseline and 3 months postoperatively	HADS (Hospital Anxiety and Depression Scale)
Frailty	baseline and 3 months postoperatively	Groningen Frailty Scale
Functional magnetic resonance imaging	baseline and 3 months postoperatively	Resting state networks
Genetic polymorphisms	baseline

Trial Locations

Locations (1)

Department of Neurology; 🇩🇪 Greifswald, Mecklenburg-Vorpommern, Germany