Myocardial ProtectionNCT03859115
Effects of TENS on Myocardial Protection in Patients Undergoing AVR
A study testing TENS (transcutaneous electrical nerve stimulation) in people with Myocardial Protection, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myocardial Protection
- What is being tested?
- TENS (transcutaneous electrical nerve stimulation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2019to 4 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing aortic valve replacement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myocardial Protection
- Being tested
- TENS (transcutaneous electrical nerve stimulation), sham intervention
- Keywords
- transcutaneous electrical nerve stimulation, sevoflurane, propofol, anesthesia, myocardial protection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS (transcutaneous electrical nerve stimulation)Procedure or surgery
transcutaneous nerve stimulation with electrical pulse generation
sham interventionProcedure or surgery
sham stimulation without electrical pulse generation
| Study group | Role | What they receive |
|---|---|---|
| preanesthesia-TENS | Active comparator | Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia. Receives: 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. Receives: Procedure: sham intervention |
| sevoflurane-TENS | Experimental | Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia. Receives: 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. Receives: Procedure: sham intervention |
| propofol-TENS | Experimental | Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia. Receives: 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. Receives: Procedure: sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size after TENS
Infarct size of rat hearts perfused with dialysate after TENS compared with sham
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start15 Mar 2019
- Primary completion8 Apr 2020
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial ProtectionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, Principal investigator, Seoul National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859115
- Sponsor's protocol ID
- TENS_AVR
- Status last verified
- Jan 2021
- First submitted
- 25 Feb 2019
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35264104
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TENS on Myocardial Protection in Patients Undergoing AVR
- ClinicalTrials.gov ID
- NCT03859115
- Acronym / sponsor ID
- TENS_AVR
- Conditions
- Myocardial Protection
- Keywords
- transcutaneous electrical nerve stimulation, sevoflurane, propofol, anesthesia, myocardial protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| preanesthesia-TENS | Active comparator | Procedure: TENS (transcutaneous electrical nerve stimulation)Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia. |
| preanesthesia-sham | Sham comparator | Procedure: sham interventionPatients in preanesthesia-sham group receive sham stimulation for 30 minutes at one arm before anesthesia. |
| sevoflurane-TENS | Experimental | Procedure: TENS (transcutaneous electrical nerve stimulation)Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia. |
| sevoflurane-sham | Active comparator | Procedure: sham interventionPatients in sevoflurane-sham group receive sham stimulation for 30 minutes at one arm under sevoflurane anesthesia. |
| propofol-TENS | Experimental | Procedure: TENS (transcutaneous electrical nerve stimulation)Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia. |
| propofol-sham | Active comparator | Procedure: sham interventionPatients in propofol-sham group receive sham stimulation for 30 minutes at one arm under propofol anesthesia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing aortic valve replacement
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS (transcutaneous electrical nerve stimulation)transcutaneous nerve stimulation with electrical pulse generation | Procedure or surgery | preanesthesia-TENS, propofol-TENS, sevoflurane-TENS |
| sham interventionsham stimulation without electrical pulse generation | Procedure or surgery | preanesthesia-sham, propofol-sham, sevoflurane-sham |
Primary outcome
Infarct size after TENS
Time frame: 30 minutes
Infarct size of rat hearts perfused with dialysate after TENS compared with sham
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 35264104Cho 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.
- Individual participant dataSharing planned: Undecided
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Myocardial Protection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunseok Jeon principal investigator
Seoul National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS (transcutaneous electrical nerve stimulation) in people with Myocardial Protection, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infarct size after TENS (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03859115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.