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
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Aneurysm Aneurysm Stent Cardiopulmonary Bypass Abdominal Aneurysm||Drug: Propofol Drug: isoflurane||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effect of Anesthesia on Potential Cerebrospinal Fluid (CSF) and Serum Markers of Alzheimer's Disease.|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
No Intervention: Open repair of thoracoabdominal aneurysms
These will be patients undergoing an open repair of thoracoabdominal aneurysms with or without cardiopulmonary bypass. The will be observational only.
Active Comparator: Stent graft repair of thoracoabdominal aneurysms isoflurane
These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive isoflurane as their primary anesthetic.
Active Comparator: Stent graft repair of thoracoabdominal aneurysms propofol
These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive propofol as their primary anesthetic.
- Changes in Cerebrospinal Fluid (CSF) Levels of Tau [ Time Frame: From insertion of spinal drain until removal ]
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 [ Time Frame: From insertion of spinal drain until removal ]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.
- Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM) [ Time Frame: Immediately after surgery and at 3 and 12 months post-op ]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.
- Serum Inflammatory Markers [ Time Frame: From the start of the surgery to 24 hours post-op ]Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772537
|United States, Maryland|
|Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Charles Brown, MD||Johns Hopkins University|