Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
Overview
- Phase
- Phase 4
- Intervention
- General anesthesia with isoflurane
- Conditions
- Alzheimers Disease
- Sponsor
- Duke University
- Enrollment
- 191
- Locations
- 1
- Primary Endpoint
- Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF), and/or changes in brain connectivity. The investigators will also examine whether different types of anesthesia have different effects on these CSF markers of Alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and CSF marker changes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Surgical patients 60 years of age or older
- •Surgery scheduled to last at least 2 hours (including time for anesthesia induction, etc)
- •English speaking ability.
- •Ability to give informed consent
Exclusion Criteria
- •Inmate of a correctional facility (i.e. prisoners).
- •Pregnancy
- •Documented or suspected family or personal history of malignant hyperthermia.
- •Patient unable to receive either propofol or isoflurane due to allergy or other specific contraindication.
Arms & Interventions
General anesthesia with Isoflurane
Patients in this arm will undergo general anesthesia with isoflurane as the primary amnestic agent.
Intervention: General anesthesia with isoflurane
Total Intravenous Anesthesia with Propofol
Patients in this arm will receive general anesthesia with propofol as the primary amnestic agent.
Intervention: Total intravenous anesthesia with propofol
Outcomes
Primary Outcomes
Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
Time Frame: Baseline to 6 weeks
Spearman correlation was used here as the CSF markers follow a skewed distribution. Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.
Correlation Between Perioperative Change in Ratios of Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
Time Frame: Baseline to 6 weeks
Spearman correlation was used here as the ratio of CSF markers follow a skewed distribution. Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.
Secondary Outcomes
- Change in CSF Markers of Alzheimers Disease by Anesthetic Agent Group(Baseline to 6 weeks)
- Change in Ratio of CSF Markers of Alzheimers Disease by Anesthetic Agent Group(baseline to 6-weeks)
- Perioperative CSF Tau/Abeta Ratio Change(Baseline to 24 hours)
- Continuous Cognitive Index Score Change Difference Between Anesthetic Agent Groups(Baseline to 6 weeks)