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

NCT01772537 | Terminated Results

• 2 other identifiers: NA_000677165KL2RR025006
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Aneurysm; Aneurysm Stent; Cardiopulmonary Bypass; Abdominal Aneurysm

Keywords

thoracoabdominal; aneurysm; open; stent; cardiopulmonary; abdominal; bypass

Outcome Measures

Primary Outcomes (2)

• Changes in Cerebrospinal Fluid (CSF) Levels of Tau

  Quantitative levels of tau will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane. .

  From insertion of spinal drain until removal

• Changes in CSF Levels of Amyloid

  Quantitative levels of amyloid will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.

  From insertion of spinal drain until removal

Secondary Outcomes (1)

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

  Immediately after surgery and at 3 and 12 months post-op

Other Outcomes (1)

• Serum Inflammatory Markers

  From the start of the surgery to 24 hours post-op

Study Arms (3)

Open repair of thoracoabdominal aneurysms

NO INTERVENTION

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

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

Drug: isoflurane

Stent graft repair of thoracoabdominal aneurysms propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Propofol DRUG

Intravenous anesthetic

Stent graft repair of thoracoabdominal aneurysms propofol

isoflurane DRUG

Stent graft repair of thoracoabdominal aneurysms isoflurane

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic; Aortic Aneurysm, Abdominal; Aneurysm

Interventions

Propofol; Isoflurane

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers

Results Point of Contact

• Title: Dr. Charles Brown
• Organization: The Johns Hopkins University

cbrown@jhmi.edu

410-955-0994

Study Officials

• Charles Brown, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: January 21, 2013
• Study Start: May 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 31, 2017
• Results First Posted: February 24, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)