Effects of TENS on Myocardial Protection in Patients Undergoing AVR

January 18, 2021 updated by: Yunseok Jeon, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: preanesthesia-TENS
Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia.
Procedure: TENS (transcutaneous electrical nerve stimulation)
transcutaneous nerve stimulation with electrical pulse generation
Sham Comparator: preanesthesia-sham
Patients in preanesthesia-sham group receive sham stimulation for 30 minutes at one arm before anesthesia.
Procedure: sham intervention
sham stimulation without electrical pulse generation
Experimental: sevoflurane-TENS
Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia.
Procedure: TENS (transcutaneous electrical nerve stimulation)
transcutaneous nerve stimulation with electrical pulse generation
Active Comparator: sevoflurane-sham
Patients in sevoflurane-sham group receive sham stimulation for 30 minutes at one arm under sevoflurane anesthesia.
Procedure: sham intervention
sham stimulation without electrical pulse generation
Experimental: propofol-TENS
Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia.
Procedure: TENS (transcutaneous electrical nerve stimulation)
transcutaneous nerve stimulation with electrical pulse generation
Active Comparator: propofol-sham
Patients in propofol-sham group receive sham stimulation for 30 minutes at one arm under propofol anesthesia.
Procedure: sham intervention
sham stimulation without electrical pulse generation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size after TENS
Time Frame: 30 minutes
Infarct size of rat hearts perfused with dialysate after TENS compared with sham
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Yunseok Jeon, Seoul National University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

April 8, 2020

Study Completion (Actual)

January 4, 2021

Study Registration Dates

First Submitted

February 25, 2019

First Submitted That Met QC Criteria

February 27, 2019

First Posted (Actual)

March 1, 2019

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 18, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TENS_AVR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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