Myocardial Protection
Conditions
Keywords
transcutaneous electrical nerve stimulation, sevoflurane, propofol, anesthesia, myocardial protection
Brief 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.
Interventions
transcutaneous nerve stimulation with electrical pulse generation
PROCEDUREsham intervention
sham stimulation without electrical pulse generation
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients undergoing aortic valve replacement
Exclusion criteria
* co-medications: metformin, nitroglycerine, nicorandil * discomfort at TENS or loss of intact skin * uncontrolled hypertension or diabetes mellitus * severely impaired renal or hepatic function * peripheral vasculopathy or neuropathy * did not consent to participate * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infarct size after TENS | 30 minutes | Infarct size of rat hearts perfused with dialysate after TENS compared with sham |
Countries
South Korea
Outcome results
None listed