Cognitive Impairment Following Elective Spine Surgery

NCT ID: NCT03486288

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

124 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-06

Study Completion Date

2021-03-30

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.

Detailed Description

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Conditions

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Cognitive Impairment Postoperative Delirium Spine Fusion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Delirium

No interventions assigned to this group

No Delirium

No interventions assigned to this group

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Fleischmann, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology

Jonas Müller, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery

Locations

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Department of Neurology

Greifswald, Mecklenburg-Vorpommern, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 32053113 (View on PubMed)

Other Identifiers

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BB 192/17

Identifier Type: -

Identifier Source: org_study_id

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