Cohort Study to Investigate the Association Between Changes in Brain Volume and Postoperative Cognitive Dysfunction

NCT02045004 | Completed DMC

• 1 other identifier: POCD-MRI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Cognitive Dysfunction; Delirium; Dementia

Keywords

Anesthesia; Surgery; Geriatrics; Postoperative cognitive dysfunction; Postoperative delirium; Dementia; Postoperative complications; Neurological complications; Psychological complications

Outcome Measures

Primary Outcomes (1)

• Cerebral gray matter volume

  Hippocampal volume is specifically assessed.

  Preoperatively, at 3 month and 12 month postoperatively

Secondary Outcomes (1)

• Cognitive function

  Preoperatively, at 7 days, 3 month and 12 month postoperatively

Study Arms (2)

Surgery Group Sevoflurane

Patients aged ≥ 65 years undergoing major surgical procedures.

Control Group

Healthy study participants aged ≥ 65 years (no surgical intervention).

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicolai Goettel: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (31)

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  PMID: 27884107 DERIVED

MeSH Terms

Conditions

Postoperative Cognitive Complications; Delirium; Dementia; Emergence Delirium; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Nicolai Goettel, MD

  Department of Anesthesia, University Hospital Basel, Switzerland

  PRINCIPAL INVESTIGATOR

• Luzius A Steiner, MD, PhD

  Department of Anesthesia, University Hospital Basel, Switzerland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Staff Anesthesiologist

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: July 14, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

CH (1)