Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of TENS on Myocardial Protection in Patients Undergoing AVR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859115
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Yunseok Jeon, Seoul National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Myocardial Protection Procedure: TENS (transcutaneous electrical nerve stimulation) Procedure: sham intervention Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of TENS on Myocardial Protection in Patients Undergoing AVR
Actual Study Start Date : March 15, 2019
Actual Primary Completion Date : April 8, 2020
Estimated Study Completion Date : April 4, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Infarct size after TENS [ Time Frame: 30 minutes ]
    Infarct size of rat hearts perfused with dialysate after TENS compared with sham


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859115


Contacts
Layout table for location contacts
Contact: Yunseok Jeon 82-2-2072-2465 jeonyunseok@gmail.com
Contact: Youn Joung Cho 82-2-2072-3108 mingming7@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Yunseok Jeon, MD, PhD    82-2-2072-2467    jeonyunseok@gmail.com   
Principal Investigator: Yunseok Jeon, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Yunseok Jeon Seoul National University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Yunseok Jeon, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03859115    
Other Study ID Numbers: TENS_AVR
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yunseok Jeon, Seoul National University Hospital:
transcutaneous electrical nerve stimulation
sevoflurane
propofol
anesthesia
myocardial protection