An interventional study of Propofol and isoflurane in Thoracic Aneurysm, Aneurysm Stent and Cardiopulmonary Bypass, sponsored by Johns Hopkins University. Terminated at 1 site in United States. Open to participants aged 21 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-03-31.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Other
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.
960 studies on the registry are indexed under Aneurysm; 174 are open to participants now.
This study's enrollment of 14 is below the median of 72 across 461 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
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.
Drug: isoflurane
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
Intravenous anesthetic
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. .
Time frame: 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.
Time frame: From insertion of spinal drain until removal
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.
Time frame: Immediately after surgery and at 3 and 12 months post-op
Serum Inflammatory Markers
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
| Milestone | Stent Graft Repair Propofol | Stent Graft Repair Isoflurane | Open Repair |
|---|---|---|---|
| Started | 5 | 3 | 6 |
| Completed | 4 | 3 | 6 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Unsuccessful lumbar drain placement | 1 | 0 | 0 |
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. .
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
| participants | Delirum Status Post Open Thoracoabdominal Aneurysm Repair | Delerium Staus Post Stenting of Aneuryms Propofol | Stent Graft Aneurysm Repair Isoflurane |
|---|---|---|---|
| Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM) | 2 | 0 | 1 |
Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stent Graft Repair Propofol | — | 0/5 (0%) | 0/5 (0%) |
| Stent Graft Repair Isoflurane | — | 0/3 (0%) | 0/3 (0%) |
| Open Thoracoabdominal Aneurysm Repair | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Stent Graft Repair Propofol | Stent Graft Repair Isoflurane | Open Repair | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 2 | 3 | 8 |
| >=65 years | 2 | 1 | 3 | 6 |
| Age, Continuous(years) | Stent Graft Repair Propofol | Stent Graft Repair Isoflurane | Open Repair | Total |
|---|---|---|---|---|
| Mean | 67 ± 13 | 62 ± 13 | 71 ± 5.3 | 65.7 ± 11.2 |
| Sex: Female, Male(Participants) | Stent Graft Repair Propofol | Stent Graft Repair Isoflurane | Open Repair | Total |
|---|---|---|---|---|
| Female | 2 | 1 | 2 | 5 |
| Male | 3 | 2 | 4 | 9 |
| Region of Enrollment(participants) | Stent Graft Repair Propofol | Stent Graft Repair Isoflurane | Open Repair | Total |
|---|---|---|---|---|
| United States | 5 | 3 | 6 | 14 |
Plan to share: No
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