Cognitive Impairment Following Elective Spine Surgery

NCT03486288 | Terminated

• 1 other identifier: BB 192/17
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• postoperative delirium - duration

  ≤ 3 days postoperatively or until delirium resolves

• postoperative delirium - severity

  ≤ 3 days postoperatively or until delirium resolves

• postoperative cognitive dysfunction - severity

  baseline and 3 months postoperatively

• pre- and postoperative intelligence

  baseline and 3 months postoperatively

• Markers of systemic inflammation

  ≤ 2 days postoperatively

Study Arms (2)

Delirium

No Delirium

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients seen in a neurosurgical oupatient clinic will be screened for eligibility.

You may qualify if:

• age ≥ 60 years
• scheduled for elective spine surgery without opening the dura
• patient can give informed consent him-/herself
• German native speaker

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Department of Neurology

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Related Publications (1)

• 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.

  PMID: 32053113 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Emergence Delirium; Delirium; Postoperative Cognitive Complications; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Inflammation

Study Officials

• Robert Fleischmann, MD

  Department of Neurology

  PRINCIPAL INVESTIGATOR

• Jonas Müller, MD

  Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: April 3, 2018
• Study Start: February 6, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 30, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

DE (1)