Effects of TENS on Myocardial Protection in Patients Undergoing AVR
NCT ID: NCT03859115
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2019-03-15
2021-01-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Near INfrared Spectroscopy in Aortic valvE ReplacemenT
NCT01251328
Clinical Implication of the Tunable Crack Sensor
NCT03805815
Transcatheter Aortic Valve Replacement (TAVR) Effects on Cardiac Conduction System
NCT04982406
TEE 3D RV Assessment for SAVR, Mini AVR, and TAVR
NCT05804240
General Anesthesia Versus Loco-Regional Anesthesia for Transcarotid Trancatheter Aortic Valve Replacement
NCT06870734
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
preanesthesia-TENS
Patients in preanesthesia-TENS group receive TENS for 30 minutes at one arm before anesthesia.
TENS (transcutaneous electrical nerve stimulation)
transcutaneous nerve stimulation with electrical pulse generation
preanesthesia-sham
Patients in preanesthesia-sham group receive sham stimulation for 30 minutes at one arm before anesthesia.
sham intervention
sham stimulation without electrical pulse generation
sevoflurane-TENS
Patients in sevoflurane-TENS group receive TENS for 30 minutes at one arm under sevoflurane anesthesia.
TENS (transcutaneous electrical nerve stimulation)
transcutaneous nerve stimulation with electrical pulse generation
sevoflurane-sham
Patients in sevoflurane-sham group receive sham stimulation for 30 minutes at one arm under sevoflurane anesthesia.
sham intervention
sham stimulation without electrical pulse generation
propofol-TENS
Patients in propofol-TENS group receive TENS for 30 minutes at one arm under propofol anesthesia.
TENS (transcutaneous electrical nerve stimulation)
transcutaneous nerve stimulation with electrical pulse generation
propofol-sham
Patients in propofol-sham group receive sham stimulation for 30 minutes at one arm under propofol anesthesia.
sham intervention
sham stimulation without electrical pulse generation
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TENS (transcutaneous electrical nerve stimulation)
transcutaneous nerve stimulation with electrical pulse generation
sham intervention
sham stimulation without electrical pulse generation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Seoul National University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yunseok Jeon
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yunseok Jeon
Role: PRINCIPAL_INVESTIGATOR
Seoul National University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TENS_AVR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.