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
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.
- Surgery under general anesthesia in elderly patients is associated with a loss of gray matter.
- 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|
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|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.
Healthy study participants aged ≥ 65 years (no surgical intervention).
- Cerebral gray matter volume [ Time Frame: Preoperatively, at 3 month and 12 month postoperatively ]Hippocampal volume is specifically assessed.
- 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.
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
|University Hospital Basel|
|Basel, Switzerland, 4031|
|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|