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

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ClinicalTrials.gov Identifier: NCT01772537
Recruitment Status : Terminated (The data did not show clear results)
First Posted : January 21, 2013
Results First Posted : February 24, 2017
Last Update Posted : March 31, 2017
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Other
Conditions Thoracic Aneurysm
Aneurysm Stent
Cardiopulmonary Bypass
Abdominal Aneurysm
Interventions Drug: Propofol
Drug: isoflurane
Enrollment 14

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stent Graft Repair Propofol Stent Graft Repair Isoflurane Open Repair
Hide Arm/Group Description

Patients have a stent graft repair receiving intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.

Propofol: Intravenous anesthetic

standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.

isoflurane

These patient will receive no intervention, just standard of care.
Period Title: Overall Study
Started 5 3 6
Completed 4 3 6
Not Completed 1 0 0
Reason Not Completed
unsuccessful lumbar drain placement             1             0             0
Arm/Group Title Stent Graft Repair Propofol Stent Graft Repair Isoflurane Open Repair Total
Hide Arm/Group Description

Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.

Propofol: Intravenous anesthetic

standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.

isoflurane

These patients received no intervention, just standard of care. Total of all reporting groups
Overall Number of Baseline Participants 5 3 6 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 6 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
2
  66.7%
3
  50.0%
8
  57.1%
>=65 years
2
  40.0%
1
  33.3%
3
  50.0%
6
  42.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 3 participants 6 participants 14 participants
67  (13) 62  (13) 71  (5.3) 65.7  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 3 participants 6 participants 14 participants
Female
2
  40.0%
1
  33.3%
2
  33.3%
5
  35.7%
Male
3
  60.0%
2
  66.7%
4
  66.7%
9
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 3 participants 6 participants 14 participants
5 3 6 14
1.Primary Outcome
Title Changes in Cerebrospinal Fluid (CSF) Levels of Tau
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data for changes in CSF levels of tau are not available. The study did not have adequate funding to appropriately measure these variables.
Arm/Group Title Propofol Isoflurane
Hide Arm/Group Description:

Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.

Propofol: Intravenous anesthetic

standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.

isoflurane

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Changes in CSF Levels of Amyloid
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data for changes in CSF levels of amyloid are not available. The study did not have adequate funding to appropriately measure these variables.
Arm/Group Title Propofol Isoflurane
Hide Arm/Group Description:

Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.

Propofol: Intravenous anesthetic

standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.

isoflurane

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 6 patients that received an open thoracoabdominal aneurysm repair 2 were found to have delirium. Of the 5 subjects that had stenting and received Propofol as their primary anesthetic, 0 were found to have delirium. Of the 3 stenting subjects that received Isoflurane as their primary anesthetic, 1 were found to have delirium.
Arm/Group Title Delirum Status Post Open Thoracoabdominal Aneurysm Repair Delerium Staus Post Stenting of Aneuryms Propofol Stent Graft Aneurysm Repair Isoflurane
Hide Arm/Group Description:
These are participants that received open thoracoabdominal aneurysm repair instead of aneurysm stenting.
These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Propofol as their primary anesthetic.
These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Isoflurane as their primary anesthetic.
Overall Number of Participants Analyzed 6 5 3
Measure Type: Number
Unit of Measure: participants
2 0 1
4.Other Pre-specified Outcome
Title Serum Inflammatory Markers
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No data is available for serum inflammatory markers. The study did not have adequate funding to appropriately measure these variables.
Arm/Group Title Propofol Isoflurane
Hide Arm/Group Description:

Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.

Propofol: Intravenous anesthetic

standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.

isoflurane

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stent Graft Repair Propofol Stent Graft Repair Isoflurane Open Thoracoabdominal Aneurysm Repair
Hide Arm/Group Description

Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.

Propofol: Intravenous anesthetic

standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.

isoflurane

These are patients that received open thoracabdominal aneurysm repair instead of aneurysm stenting.
All-Cause Mortality
Stent Graft Repair Propofol Stent Graft Repair Isoflurane Open Thoracoabdominal Aneurysm Repair
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stent Graft Repair Propofol Stent Graft Repair Isoflurane Open Thoracoabdominal Aneurysm Repair
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/3 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stent Graft Repair Propofol Stent Graft Repair Isoflurane Open Thoracoabdominal Aneurysm Repair
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/3 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Charles Brown
Organization: The Johns Hopkins University
Phone: 410-955-0994
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01772537     History of Changes
Other Study ID Numbers: NA_00067716
5KL2RR025006 ( U.S. NIH Grant/Contract )
First Submitted: January 17, 2013
First Posted: January 21, 2013
Results First Submitted: September 20, 2016
Results First Posted: February 24, 2017
Last Update Posted: March 31, 2017