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Completed

NCT Number: NCT03859115

Effects of TENS on Myocardial Protection in Patients Undergoing AVR

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.

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Key information

Conditions

Myocardial Protection

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS (transcutaneous electrical nerve stimulation)

Procedure

transcutaneous nerve stimulation with electrical pulse generation

sham intervention

Procedure

sham stimulation without electrical pulse generation

Primary outcomes

  1. Infarct size after TENS

    Time frame: 30 minutes

    Infarct size of rat hearts perfused with dialysate after TENS compared with sham

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 1, 2019
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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