Markers of Alzheimers Disease After Propofol or Isoflurane Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-03-31

Brief Summary

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Previous work in animal models suggests that inhalational anesthetic agents may accelerate Alzheimer's disease pathogenesis, but it is unclear to what extent this may happen in humans. Here, the investigators propose to measure Alzheimer's disease-related neural markers in the cerebrospinal fluid (CSF) of patients exposed to anesthesia while undergoing neurosurgical procedures that require lumbar drain placement. Patients will be randomized to either receive inhalation anesthesia with isoflurane or intravenous anesthesia with propofol.

CSF and blood samples will each be collected at the induction of anesthesia, and then again ten and twenty-four hours later. CSF samples will be assayed for amyloid beta, tau, and other Alzheimer's disease-associated markers; blood samples will be assayed for serum inflammatory markers and used for genotyping studies. These studies should clarify the effect of common anesthetic agents on Alzheimer's disease related neural markers.

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Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol based intravenous anesthesia

patients will receive propofol based intravenous anesthesia

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

patients randomized to the propofol arm of the study will receive general anesthesia with propofol

Isoflurane Based Inhaled Anesthesia

patients will receive isoflurane based inhaled anesthesia

Group Type EXPERIMENTAL

Isoflurane

Intervention Type DRUG

patients randomized to the isoflurane arm of the study will receive general anesthesia with isoflurane

Interventions

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Propofol

patients randomized to the propofol arm of the study will receive general anesthesia with propofol

Intervention Type DRUG

Isoflurane

patients randomized to the isoflurane arm of the study will receive general anesthesia with isoflurane

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 18 and above
* seen in neurosurgical clinic, and scheduled for operative aneurysm repair or other neurosurgical procedure necessitating lumbar drain placement.
* ability to speak English.
* ability to understand consent forms, and to give informed consent.

Exclusion Criteria

* age less than 18
* lumbar drain is not placed
* not eligible for one of the anesthetics (inhaled isoflurane or IV propofol)
* inmate of a correctional facility (i.e. prisoners).
* pregnancy. Pregnancy is ruled out as standard of care before cranial surgery, based on clinical history and/or HCG testing

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No