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

Primary Purpose

Thoracic Aneurysm, Aneurysm Stent, Cardiopulmonary Bypass

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Propofol
isoflurane
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Thoracic Aneurysm focused on measuring thoracoabdominal, aneurysm, open, stent, cardiopulmonary, abdominal, bypass

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Open repair of thoracoabdominal aneurysms

Stent graft repair of thoracoabdominal aneurysms isoflurane

Stent graft repair of thoracoabdominal aneurysms propofol

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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. .
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.

Secondary Outcome Measures

Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)
Delirium was measured using the Confusion Assessment Method and the Confusion Assessment Method- Intensive Care Unit (CAM-ICU) based upon post-operative location of patient. The patients were divided into to two groups, patients that had an open thoracoabdominal aneurysm repair versus patients that had stenting of their aneurysms. Patients that had stenting of their aneurysms were also randomized to receive either Propofol or Isoflurane as for their anesthetic.

Full Information

First Posted
January 17, 2013
Last Updated
March 2, 2017
Sponsor
Johns Hopkins University
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT01772537
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
The data did not show clear results
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Aneurysm, Aneurysm Stent, Cardiopulmonary Bypass, Abdominal Aneurysm
Keywords
thoracoabdominal, aneurysm, open, stent, cardiopulmonary, abdominal, bypass

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open repair of thoracoabdominal aneurysms
Arm Type
No Intervention
Arm Description
These will be patients undergoing an open repair of thoracoabdominal aneurysms with or without cardiopulmonary bypass. The will be observational only.
Arm Title
Stent graft repair of thoracoabdominal aneurysms isoflurane
Arm Type
Active Comparator
Arm 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.
Arm Title
Stent graft repair of thoracoabdominal aneurysms propofol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Intravenous anesthetic
Intervention Type
Drug
Intervention Name(s)
isoflurane
Primary Outcome Measure Information:
Title
Changes in Cerebrospinal Fluid (CSF) Levels of Tau
Description
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. .
Time Frame
From insertion of spinal drain until removal
Title
Changes in CSF Levels of Amyloid
Description
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.
Time Frame
From insertion of spinal drain until removal
Secondary Outcome Measure Information:
Title
Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)
Description
Delirium was measured using the Confusion Assessment Method and the Confusion Assessment Method- Intensive Care Unit (CAM-ICU) based upon post-operative location of patient. The patients were divided into to two groups, patients that had an open thoracoabdominal aneurysm repair versus patients that had stenting of their aneurysms. Patients that had stenting of their aneurysms were also randomized to receive either Propofol or Isoflurane as for their anesthetic.
Time Frame
Immediately after surgery and at 3 and 12 months post-op
Other Pre-specified Outcome Measures:
Title
Serum Inflammatory Markers
Description
Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured
Time Frame
From the start of the surgery to 24 hours post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Brown, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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