The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm.

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-02-28

Brief Summary

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Alzheimer's disease represents a growing public health problem in developed countries. Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid, neurofibrillary tangles and neuronal loss are the hallmarks of Alzheimer's disease. The effect of anesthetic agents on changes in these proteins in humans is not well characterized, but in-vitro evidence suggests that anesthetic agents can accelerate potential pathogenic mechanisms, such as increasing amyloid formation or rates of apoptosis in cultured cells and increasing amyloid levels in mice. Human data on the effect of anesthetic agents on amyloid and tau proteins is limited to a small series of 11 patients and showed a significant increase in tau levels after exposure to anesthetics. In this study the investigators propose to measure CSF and serum biomarkers in a population of patients with normal CSF dynamics, who are undergoing surgery for repair of a thoracoabdominal aneurysm. The investigators will also obtain preliminary data on whether changes in CSF levels of these proteins are associated with postoperative delirium or cognitive change.

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Detailed Description

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Conditions

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Thoracic Aneurysm Aneurysm Stent Cardiopulmonary Bypass Abdominal Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Open repair of thoracoabdominal aneurysms

These will be patients undergoing an open repair of thoracoabdominal aneurysms with or without cardiopulmonary bypass. The will be observational only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Stent graft repair of thoracoabdominal aneurysms isoflurane

These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive isoflurane as their primary anesthetic.

Group Type ACTIVE_COMPARATOR

isoflurane

Intervention Type DRUG

Stent graft repair of thoracoabdominal aneurysms propofol

These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive propofol as their primary anesthetic.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Intravenous anesthetic

Interventions

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Propofol

Intravenous anesthetic

Intervention Type DRUG

isoflurane

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age 21-100 years of age
* Patients presenting for surgical repair of a thoracoabdominal aneurysm
* Insertion of a CSF spinal drain for clinically indicated reason

Exclusion Criteria

* Patients with pre-existing delirium
* Inability to speak and understand English
* Severe hearing impairment, resulting in inability to converse
* Pregnancy. Pregnancy status will be assessed using a serum pregnancy test during preoperative evaluation as part of the standard of care.

Minimum Eligible Age

21 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No