Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03859115 |
Other study ID # |
TENS_AVR |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 15, 2019 |
Est. completion date |
January 4, 2021 |
Study information
Verified date |
January 2021 |
Source |
Seoul National University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Patients undergoing aortic valve replacement are randomized to receive TENS (transcutaneous
electrical nerve stimulation) or sham stimulation at one arm for 30 min under various
anesthetic conditions: no anesthesia (preanesthesia), sevoflurane or propofol anesthesia.
Cardioprotective effects of TENS are compared through Langendorff rat heart perfusion system
using plasma dialysate from patients.
Description:
Patients undergoing aortic valve replacement are randomized to one of six groups:
preanesthesia-TENS (transcutaneous electrical nerve stimulation), preanesthesia-sham,
sevoflurane-TENS, sevoflurane-sham, propofol-TENS, propofol-sham. Patients receive TENS or
sham stimulation (without electrical pulse generation) at one arm for 30 min under no
anesthesia (preanesthesia) or sevoflurane or propofol anesthesia.
In all patients, blood samples are obtained before and after TENS or sham procedure to make
plasma dialysate to perfuse rat hearts subjected to ischemia-reperfusion injury through
Langendorff system.
Cardioprotective effects are determined by comparing infarct sizes of rat hearts perfused
with human plasma dialysate, which reflects cardioprotective effects of TENS in human
subjects. By comparing infarct size differences, the myocardial protective effects of TENS in
various anesthetic conditions can be determined in human subjects undergoing aortic valve
replacement.