Cohort Study of Risk Factors for Postoperative Cognitive Decline (POCD)

Presently, the role of either genetic factors or biological sex in the development of postoperative cognitive dysfunction (POCD) is unknown. There is a critical need to determine which individuals are at high-risk for developing POCD by virtue of biological sex or genetic predisposition. The knowledge gained in the described research has the potential to shed light on mechanistic pathways, a necessary next step in order to ultimately identify therapeutic strategies.

Study Overview

• Status: Completed
• Conditions: Cognitive Decline

Detailed Description

Adults 65 years and older represent the fastest-growing age group in the United States, and account for one third of all surgical patients. These older adults are at the highest risk for deleterious postoperative neurocognitive outcomes. Postoperative cognitive dysfunction (POCD) occurs in up to 40% of older adults after major non-cardiac surgery. POCD is a syndrome characterized by a decrease in performance on neuropsychological test battery from before to after surgery. Neuropsychological testing for POCD typically spans cognitive domains including memory, attention, concentration, and/or executive function. There is an increasing body of literature suggesting that exposure to surgery and anesthesia increases the risk of Alzheimer's disease (AD). Surgery and anesthesia enhance neuropathologic changes known to underlie AD including amyloid beta accumulation and aggregation, neuroinflammation, increased levels of tau and tau phosphorylation, and memory decline. However, not everyone with a history of surgery and anesthesia develops POCD, suggesting biological risk factors are involved.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 89 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects who present to spine clinic

Description

Inclusion Criteria:

• Scheduled for an in-patient, elective spine surgery where subject will receive general anesthesia
• Presenting to spine clinic and undergoing conservative, non-surgical management of spine disorder
• Subjects must have sufficient vision and hearing to complete neuropsychological testing
• Proficient in spoken and written English language

Exclusion Criteria:

• Diagnosed dementia or dementia-related treatment (i.e. donepezil prescription, or memory-care facility residence)
• Significant disease of the central nervous system (CNS) (i.e. Parkinson's disease)
• History of stroke or traumatic brain injury
• Major psychiatric disorder (i.e. schizophrenia)
• Alcohol or drug abuse according to DSM-V within the last 2 years
• Need for urgent/emergent surgery
• Surgery/anesthesia within prior 12 months
• Refusal of consent

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
In-patient spine surgery; Scheduled for an in-patient, elective spine surgery where subject will receive general anesthesia
Non-surgical spine care; Presenting to spine clinic and undergoing conservative, non-surgical management of spine disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic Variables	To determine whether specific genetic variables (i.e. APOE4 or PLA2 alleles) and/or biological sex confer a higher risk to developing postoperative cognitive and functional status decline in older adults.	Six months

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Katie Schenning, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): May 20, 2022
• Study Completion (Actual): May 20, 2022

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Anesthesia, Risk Factors, Age
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 17595

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No