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

This study has been terminated.
(The data did not show clear results)
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01772537
First received: January 17, 2013
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
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 we 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. We will also obtain preliminary data on whether changes in CSF levels of these proteins are associated with postoperative delirium or cognitive change.

Condition Intervention
Open Thoracoabdominal Aneurysm Repair
Thoracoabdominal Aneurysm Stent
Thoracoabdominal Aneurysm Repair With Cardiopulmonary Bypass
Abdominal Aneurysm
Drug: Propofol
Drug: isoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: The Effect of Anesthesia on Potential CSF and Serum Markers of Alzheimer's Disease.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Changes in CSF levels of tau and amyloid [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delirium and cognitive change [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Serum inflammatory markers [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol
Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.
Drug: Propofol
Intravenous anesthetic
Active Comparator: Isoflurane
standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
Drug: isoflurane

  Eligibility

Ages Eligible for Study:   21 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772537

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Charles Brown, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01772537     History of Changes
Other Study ID Numbers: NA_00067716  5KL2RR025006 
Study First Received: January 17, 2013
Last Updated: July 25, 2016
Health Authority: United States: The Johns Hopkins University Institutional Review Board

Keywords provided by Johns Hopkins University:
thoracoabdominal
aneurysm
open
stent
cardiopulmonary
abdominal
bypass

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases
Propofol
Anesthetics, Intravenous
Anesthetics
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, General
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on September 29, 2016