Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-01-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimers Disease Postoperative Delirium Post Operative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Total Intravenous Anesthesia with Propofol

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

Group Type ACTIVE_COMPARATOR

Total intravenous anesthesia with propofol

Intervention Type DRUG

General anesthesia with Isoflurane

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

Group Type ACTIVE_COMPARATOR

General anesthesia with isoflurane

Intervention Type DRUG

Interventions

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Total intravenous anesthesia with propofol

Intervention Type DRUG

General anesthesia with isoflurane

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No