ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02045004
Recruitment Status : Active, not recruiting
First Posted : January 24, 2014
Last Update Posted : April 25, 2018
Sponsor:
Collaborator:
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

  Show Detailed Description

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
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Sevoflurane

Group/Cohort
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
Criteria

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


Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Nicolai Goettel
University Hospital, Basel, Switzerland
Investigators
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nicolai Goettel, MD, Staff Anesthesiologist, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02045004     History of Changes
Other Study ID Numbers: POCD-MRI
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nicolai Goettel, University Hospital, Basel, Switzerland:
Anesthesia
Surgery
Geriatrics
Postoperative cognitive dysfunction
Postoperative delirium
Dementia
Postoperative complications
Neurological complications
Psychological complications

Additional relevant MeSH terms:
Brain Diseases
Dementia
Delirium
Cognitive Dysfunction
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cognition Disorders
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs