NCT03859115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
14 days until next milestone

Study Start

First participant enrolled

March 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.1 years

First QC Date

February 25, 2019

Last Update Submit

January 18, 2021

Conditions

Myocardial Protection

Keywords

transcutaneous electrical nerve stimulationsevofluranepropofolanesthesiamyocardial protection

Outcome Measures

Primary Outcomes (1)

  • Infarct size after TENS

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

    30 minutes

Study Arms (6)

preanesthesia-TENS

ACTIVE COMPARATOR

Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia.

Procedure: TENS (transcutaneous electrical nerve stimulation)

preanesthesia-sham

SHAM COMPARATOR

Patients in preanesthesia-sham group receive sham stimulation for 30 minutes at one arm before anesthesia.

Procedure: sham intervention

sevoflurane-TENS

EXPERIMENTAL

Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia.

Procedure: TENS (transcutaneous electrical nerve stimulation)

sevoflurane-sham

ACTIVE COMPARATOR

Patients in sevoflurane-sham group receive sham stimulation for 30 minutes at one arm under sevoflurane anesthesia.

Procedure: sham intervention

propofol-TENS

EXPERIMENTAL

Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia.

Procedure: TENS (transcutaneous electrical nerve stimulation)

propofol-sham

ACTIVE COMPARATOR

Patients in propofol-sham group receive sham stimulation for 30 minutes at one arm under propofol anesthesia.

Procedure: sham intervention

Interventions

TENS (transcutaneous electrical nerve stimulation)PROCEDURE

transcutaneous nerve stimulation with electrical pulse generation

preanesthesia-TENSpropofol-TENSsevoflurane-TENS
sham interventionPROCEDURE

sham stimulation without electrical pulse generation

preanesthesia-shampropofol-shamsevoflurane-sham

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing aortic valve replacement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Cho YJ, Jung DE, Nam K, Bae J, Lee S, Jeon Y. Effects of transcutaneous electrical nerve stimulation on myocardial protection in patients undergoing aortic valve replacement: a randomized clinical trial. BMC Anesthesiol. 2022 Mar 9;22(1):68. doi: 10.1186/s12871-022-01611-x.

    PMID: 35264104DERIVED

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Yunseok Jeon

    Seoul National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 1, 2019

Study Start

March 15, 2019

Primary Completion

April 8, 2020

Study Completion

January 4, 2021

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

KR(1)