Effects of TENS on Myocardial Protection in Patients Undergoing AVR

Myocardial Protection Clinical Trial

Official title:

Effects of TENS on Myocardial Protection in Patients Undergoing AVR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859115
• Other study ID #: TENS_AVR
• Status: Completed
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 4, 2021
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Protection

Intervention

Procedure:
• TENS (transcutaneous electrical nerve stimulation)
transcutaneous nerve stimulation with electrical pulse generation
• sham intervention
sham stimulation without electrical pulse generation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infarct size after TENS	Infarct size of rat hearts perfused with dialysate after TENS compared with sham	30 minutes