Clinical trial NCT01993836: Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
Official title: Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimers Disease
Postoperative Delirium
Post Operative Cognitive Dysfunction
Keywords: isoflurane
propofol
total intravenous anesthesia
inhaled anesthetic
volatile anesthetic
anesthesia
delirium
Post Operative Cognitive Dysfunction
Alzheimer's Disease
Mild Cognitive Impairment
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 191
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
timeFrame: Baseline to 6 weeks
measure: Correlation Between Perioperative Change in Ratios of Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Continuous Cognitive Index Score Change Difference Between Anesthetic Agent Groups
timeFrame: Baseline to 6 weeks
measure: Change in CSF Markers of Alzheimers Disease by Anesthetic Agent Group
timeFrame: Baseline to 6 weeks
measure: Change in Ratio of CSF Markers of Alzheimers Disease by Anesthetic Agent Group
timeFrame: baseline to 6-weeks
measure: Perioperative CSF Tau/Abeta Ratio Change
timeFrame: Baseline to 24 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Anesthesiology Department, Neuroanesthesia Division
name: Miles Berger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger M, Browndyke JN, Cooter Wright M, Nobuhara C, Reese M, Acker L, Bullock WM, Colin BJ, Devinney MJ, Moretti EW, Moul JW, Ohlendorf B, Laskowitz DT, Waligorska T, Shaw LM, Whitson HE, Cohen HJ, Mathew JP; MADCO-PC Investigators. Postoperative changes in cognition and cerebrospinal fluid neurodegenerative disease biomarkers. Ann Clin Transl Neurol. 2022 Feb;9(2):155-170. doi: 10.1002/acn3.51499. Epub 2022 Feb 1.