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Cohort Study to Investigate the Association Between Changes in Brain Volume and Postoperative Cognitive Dysfunction (POCD-MRI)

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ClinicalTrials.gov Identifier: NCT02045004
Recruitment Status : Completed
First Posted : January 24, 2014
Last Update Posted : November 23, 2018
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
Nicolai Goettel, University Hospital, Basel, Switzerland

Brief Summary:

Despite an ongoing controversy in the scientific literature, the link between anesthesia and dementia and/or cerebral atrophy remains unclear. Recent retrospective data suggests an association of surgery with a reduction in brain volume. With the present prospective cohort study, we would like to reproduce and verify these results, and investigate a possible association with the postoperative cognitive performance.

We will measure cerebral gray matter volumes in elderly patients before, 3 and 12 months after major non-cardiac surgery and determine cognitive functions at the same time.

Study hypothesis:

  1. Surgery under general anesthesia in elderly patients is associated with a loss of gray matter.
  2. The degree of cognitive dysfunction is associated with the loss of grey matter in brain areas relevant for cognitive functions.

Condition or disease
Postoperative Cognitive Dysfunction Delirium Dementia

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Changes in Cerebral Gray Matter Volume and Postoperative Cognitive Dysfunction in Elderly Patients Following Sevoflurane Anesthesia (POCD-MRI)
Actual Study Start Date : July 14, 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2018

Surgery Group Sevoflurane
Patients aged ≥ 65 years undergoing major surgical procedures.
Control Group
Healthy study participants aged ≥ 65 years (no surgical intervention).

Primary Outcome Measures :
  1. Cerebral gray matter volume [ Time Frame: Preoperatively, at 3 month and 12 month postoperatively ]
    Hippocampal volume is specifically assessed.

Secondary Outcome Measures :
  1. Cognitive function [ Time Frame: Preoperatively, at 7 days, 3 month and 12 month postoperatively ]
    The neuropsychological assessment test battery CERAD-Plus consistent of the Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB), Trail Making Tests A+B, and phonetic fluency (s-words), as well as the Test for Attentional Performance (TAP) developed to analyze different aspects of attention, will be performed. Cognitive functions will be quantified using the CERAD total score, in its demographically corrected form.

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants in Group 1 (Surgery group Sevoflurane) will be recruited as patients of the Basel University Hospital, a tertiary medical center affilitated to the University of Basel, Switzerland. Study participants in Group 2 (Control group) will be recruited randomly from the local population.

Inclusion Criteria:

  • Age ≥ 65 years
  • Elective major surgery
  • Planned general anesthesia

Exclusion Criteria:

  • Cardiac surgery
  • Neurosurgery including carotid endarterectomy
  • Preoperative Mini Mental State (MMS) Examination Score < 24
  • Previous pathological neuroimaging (if available)
  • History of cerebral or cerebrovascular pathology
  • Chronic use of psychiatric medication
  • Alcohol or substance abuse
  • A history of chronic pain unrelated to the planned surgery
  • Any contraindication for MRI (e.g. pacemakers and other MR-incompatible metal implants)
  • Claustrophobia
  • Lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045004

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University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Nicolai Goettel
University Hospital, Basel, Switzerland
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Principal Investigator: Nicolai Goettel, MD Department of Anesthesia, University Hospital Basel, Switzerland
Study Chair: Luzius A Steiner, MD, PhD Department of Anesthesia, University Hospital Basel, Switzerland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nicolai Goettel, MD, Staff Anesthesiologist, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02045004    
Other Study ID Numbers: POCD-MRI
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: November 23, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nicolai Goettel, University Hospital, Basel, Switzerland:
Postoperative cognitive dysfunction
Postoperative delirium
Postoperative complications
Neurological complications
Psychological complications
Additional relevant MeSH terms:
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Postoperative Cognitive Complications
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Cognition Disorders
Postoperative Complications
Pathologic Processes