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

Johns Hopkins University

Status: Terminated

Conditions: Abdominal Aneurysm; Cardiopulmonary Bypass; Thoracic Aneurysm; Aneurysm Stent

Treatments: Drug: Propofol; Drug: isoflurane

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01772537

NA_00067716

5KL2RR025006 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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14 participants in 3 patient groups

Open repair of thoracoabdominal aneurysms

No Intervention group

Description:

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

Stent graft repair of thoracoabdominal aneurysms isoflurane

Active Comparator group

Description:

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

Treatment:

Drug: isoflurane

Stent graft repair of thoracoabdominal aneurysms propofol

Active Comparator group

Description:

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

Treatment:

Drug: Propofol