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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preanesthesia-TENS | Active Comparator | Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia. |
|
| preanesthesia-sham | Sham Comparator | Patients in preanesthesia-sham group receive sham stimulation for 30 minutes at one arm before anesthesia. |
|
| sevoflurane-TENS | Experimental | Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia. |
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| sevoflurane-sham | Active Comparator | Patients in sevoflurane-sham group receive sham stimulation for 30 minutes at one arm under sevoflurane anesthesia. |
|
| propofol-TENS | Experimental | Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS (transcutaneous electrical nerve stimulation) | Procedure | transcutaneous nerve stimulation with electrical pulse generation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infarct size after TENS | Infarct size of rat hearts perfused with dialysate after TENS compared with sham | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunseok Jeon | Seoul National University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35264104 | Derived | Cho YJ, Jung DE, Nam K, Bae J, Lee S, Jeon Y. Effects of transcutaneous electrical nerve stimulation on myocardial protection in patients undergoing aortic valve replacement: a randomized clinical trial. BMC Anesthesiol. 2022 Mar 9;22(1):68. doi: 10.1186/s12871-022-01611-x. |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| propofol-sham | Active Comparator | Patients in propofol-sham group receive sham stimulation for 30 minutes at one arm under propofol anesthesia. |
|
| sham intervention | Procedure | sham stimulation without electrical pulse generation |
|
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |