Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care (MADCO-PC)
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.
Post Operative Cognitive Dysfunction
Drug: Total intravenous anesthesia with propofol
Drug: General anesthesia with isoflurane
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care|
- Perioperative CSF Tau/Abeta ratio change [ Time Frame: 24 hours ] [ Designated as safety issue: No ]We will measure the perioperative change in the CSF tau/Abeta ratio from the start of anesthesia/surgery to 24 hours later.
- Continuous cognitive index score change [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]We will examine the difference in the continuous cognitive index score over time in the subjects treated with propofol versus those treated with isoflurane.
- Assess the correlation between perioperative change in CSF Markers of Alzheimers Disease and perioperative cognitive change. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]We will assess the magnitude of the pearson correlation coefficient for the relationship between perioperative change in CSF Markers of Alzheimers Disease and the perioperative change in the continuous cognitive index score.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Total Intravenous Anesthesia with Propofol
Patients in this arm will receive general anesthesia with propofol as the primary amnestic agent.
|Drug: Total intravenous anesthesia with propofol|
Active Comparator: General anesthesia with Isoflurane
Patients in this arm will undergo general anesthesia with isoflurane as the primary amnestic agent.
|Drug: General anesthesia with isoflurane|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01993836
|Contact: Miles Berger, MD, PhDfirstname.lastname@example.org|
|United States, North Carolina|
|Duke University Medical Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Miles Berger, MD, PhD email@example.com|
|Contact: Carlos Conde firstname.lastname@example.org|
|Principal Investigator: Miles Berger, MD, PhD|
|Principal Investigator:||Miles Berger, MD, PhD||Duke University Medical Center, Anesthesiology Department, Neuroanesthesia Division|