Trials / Completed
CompletedNCT03859115
Effects of TENS on Myocardial Protection in Patients Undergoing AVR
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | TENS (transcutaneous electrical nerve stimulation) | transcutaneous nerve stimulation with electrical pulse generation |
| PROCEDURE | sham intervention | sham stimulation without electrical pulse generation |
Timeline
- Start date
- 2019-03-15
- Primary completion
- 2020-04-08
- Completion
- 2021-01-04
- First posted
- 2019-03-01
- Last updated
- 2021-01-20
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03859115. Inclusion in this directory is not an endorsement.