Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care (MADCO-PC)

Duke University

Status and phase: Completed; Phase 4

Conditions: Alzheimers Disease; Post Operative Cognitive Dysfunction; Postoperative Delirium

Treatments: Drug: General anesthesia with isoflurane; Drug: Total intravenous anesthesia with propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT01993836

Pro00045180

Details and patient eligibility

About

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.

Enrollment: 191 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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191 participants in 2 patient groups

Total Intravenous Anesthesia with Propofol

Active Comparator group

Description:

Patients in this arm will receive general anesthesia with propofol as the primary amnestic agent.

Treatment:

Drug: Total intravenous anesthesia with propofol

General anesthesia with Isoflurane

Active Comparator group

Description:

Patients in this arm will undergo general anesthesia with isoflurane as the primary amnestic agent.

Treatment:

Drug: General anesthesia with isoflurane