Effects of TENS on Myocardial Protection in Patients Undergoing AVR

Seoul National University

Status: Completed

Conditions: Myocardial Protection

Treatments: Procedure: sham intervention; Procedure: TENS (transcutaneous electrical nerve stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT03859115

TENS_AVR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 6 patient groups

preanesthesia-TENS

Active Comparator group

Description:

Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia.

Treatment:

Procedure: TENS (transcutaneous electrical nerve stimulation)

preanesthesia-sham

Sham Comparator group

Description:

Patients in preanesthesia-sham group receive sham stimulation for 30 minutes at one arm before anesthesia.

Treatment:

Procedure: sham intervention

sevoflurane-TENS

Experimental group

Description:

Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia.

Treatment:

Procedure: TENS (transcutaneous electrical nerve stimulation)

sevoflurane-sham

Active Comparator group

Description:

Patients in sevoflurane-sham group receive sham stimulation for 30 minutes at one arm under sevoflurane anesthesia.

Treatment:

Procedure: sham intervention

propofol-TENS

Experimental group

Description:

Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia.

Treatment:

Procedure: TENS (transcutaneous electrical nerve stimulation)

propofol-sham

Active Comparator group

Description:

Patients in propofol-sham group receive sham stimulation for 30 minutes at one arm under propofol anesthesia.

Treatment:

Procedure: sham intervention