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

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Abdominal aortic aneurysm
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Brief Title

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

Official Title

The Effect of Anesthesia on Potential Cerebrospinal Fluid (CSF) and Serum Markers of Alzheimer's Disease.

Brief Summary

      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.

Study Type

Interventional

Primary Outcome

Changes in Cerebrospinal Fluid (CSF) Levels of Tau

Secondary Outcome

 Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)

Condition

Thoracic Aneurysm

Intervention

Propofol

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

14

Start Date

May 2012

Completion Date

February 2014

Primary Completion Date

February 2014

Eligibility Criteria

        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.

Gender

All

Ages

21 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Charles Brown, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT01772537

Organization ID

NA_00067716

Secondary IDs

5KL2RR025006

Responsible Party

Sponsor

Study Sponsor

Johns Hopkins University

Collaborators

 National Center for Research Resources (NCRR)

Study Sponsor

Charles Brown, MD, Principal Investigator, Johns Hopkins University

Verification Date

March 2017