Effects of TENS on Myocardial Protection in Patients Undergoing AVR

Not Applicable

Completed

• Conditions: Myocardial Protection
• Interventions: Procedure: sham intervention; Procedure: TENS (transcutaneous electrical nerve stimulation)

• Registration Number: NCT03859115
• Lead Sponsor: Seoul National University Hospital

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.

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 Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-03-01
• Study Start: 2019-03-15
• Primary Completion: 2020-04-08
• Status Verified: 2021-01
• Study Completion: 2021-01-04
• Last Update Submitted: 2021-01-18
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sevoflurane-sham	sham intervention	Patients in sevoflurane-sham group receive sham stimulation for 30 minutes at one arm under sevoflurane anesthesia.
propofol-sham	sham intervention	Patients in propofol-sham group receive sham stimulation for 30 minutes at one arm under propofol anesthesia.
preanesthesia-TENS	TENS (transcutaneous electrical nerve stimulation)	Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia.
preanesthesia-sham	sham intervention	Patients in preanesthesia-sham group receive sham stimulation for 30 minutes at one arm before anesthesia.
sevoflurane-TENS	TENS (transcutaneous electrical nerve stimulation)	Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia.
propofol-TENS	TENS (transcutaneous electrical nerve stimulation)	Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia.

Primary Outcome Measures

Name	Time	Method
Infarct size after TENS	30 minutes	Infarct size of rat hearts perfused with dialysate after TENS compared with sham

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of