Clinical trial NCT03486288: Cognitive Impairment Following Elective Spine Surgery
Official title: Kognitive Störungen Nach Elektiver Wirbelsäulenchirurgie Bei Älteren
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cognitive Impairment
Postoperative Delirium
Spine Fusion
Keywords: delirium
postoperative cognitive dysfunction
spine surgery
elderly
neuroinflammation
magnetic resonance imaging
resting state fmri
cerebral vasculature
quality of life
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 124
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients seen in a neurosurgical oupatient clinic will be screened for eligibility.

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.


Eligibility criteria: 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

Primary outcomes:
measure: postoperative delirium - incidence
timeFrame: ≤ 3 days postoperatively
Secondary outcomes:
measure: postoperative delirium - duration
timeFrame: ≤ 3 days postoperatively or until delirium resolves
measure: postoperative delirium - severity
timeFrame: ≤ 3 days postoperatively or until delirium resolves
measure: postoperative cognitive dysfunction - severity
timeFrame: baseline and 3 months postoperatively
measure: pre- and postoperative intelligence
timeFrame: baseline and 3 months postoperatively
measure: Markers of systemic inflammation
timeFrame: ≤ 2 days postoperatively
measure: Markers of neuroinflammation
timeFrame: ≤ 2 days postoperatively
measure: Markers of oxidative and metabolic stress
timeFrame: ≤ 2 days postoperatively
measure: Patient Reported Quality of life
timeFrame: baseline and 3 months postoperatively
measure: Patient Reported Quality of life - 2
timeFrame: baseline and 3 months postoperatively
measure: Anxiety and depression
timeFrame: baseline and 3 months postoperatively
measure: Frailty
timeFrame: baseline and 3 months postoperatively
measure: Structural magnetic resonance imaging
timeFrame: baseline and 3 months postoperatively
measure: Functional magnetic resonance imaging
timeFrame: baseline and 3 months postoperatively
measure: Cerebral vasculature
timeFrame: baseline
measure: Genetic polymorphisms
timeFrame: baseline
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Department of Neurology
state: Mecklenburg-Vorpommern
Study officials:
affiliation: Department of Neurology
name: Robert Fleischmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery
name: Jonas Müller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller J, Nowak S, Vogelgesang A, von Sarnowski B, Rathmann E, Schmidt S, Rehberg S, Usichenko T, Kertscho H, Hahnenkamp K, Floel A, Schroeder HW, Muller JU, Fleischmann R. Evaluating Mechanisms of Postoperative Delirium and Cognitive Dysfunction Following Elective Spine Surgery in Elderly Patients (CONFESS): Protocol for a Prospective Observational Trial. JMIR Res Protoc. 2020 Feb 13;9(2):e15488. doi: 10.2196/15488.