Investigation of the Effectiveness of Electroacupuncture in Patients Undergoing Coronary Artery Bypass Surgery.

September 13, 2025 updated by: Yavuz Orak, Kahramanmaras Sutcu Imam University

Investigation of the Hemodynamic, Cardioprotective and Anti-inflammatory Effectiveness of Electroacupuncture in Patients Undergoing Coronary Artery Bypass Surgery: Randomized, Controlled Study.

In China, acupuncture has been used for nearly 5,000 years to treat diseases and symptoms.

Increasing evidence suggests that acupuncture, acupressure, and electroacupuncture (EA) may be useful in treating patients with cardiovascular disease. Electroacupuncture is a combination of traditional Chinese acupuncture and modern electrical techniques. The PC6 (Neiguan) acupoint is believed to influence cardiovascular function and treat a wide range of heart diseases, including angina pectoris, myocardial infarction, hypertension and hypotension.

According to traditional Chinese medicine theory, PC 6 (Neiguan) and LU 7 (Lieque) are important acupuncture points where two main meridians meet each other. LU 7 and LU 2 (Yunmen) belong to the same meridian. Three acupuncture points have coordinated effects and act together. These points are the most commonly used areas to treat heart diseases in China and other countries and have been selected as suitable points in studies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a prospective, randomized and controlled study and will be conducted in patients who underwent cardiopulmonary bypass and coronary artery surgery.Randomized patients will be randomly divided into two groups as follows. Acupuncture group; Group A and Control group: Group C. In this study, the patients' age, gender, body mass index (BMI), smoking, comorbidities, left ventricular ejection/fraction (E/F), cardiopulmonary bypass time (CPBS, min), aortic cross-clamp time (ACCS, min). , operation duration, amount of cardioplegia, lowest body temperature will be recorded. Electroacupuncture will be applied to the patients for 30 minutes by the conductor of the study, who is an acupuncturist experienced in electroacupuncture, on the day before surgery and on the day of surgery.The placement of the needles will be applied to a depth of 1-2 cm, depending on the thickness of the local tissues, according to Traditional Chinese Medicine standards.The EA parameter will be set to a frequency of 2 HZ/100 HZ at a current that the patients' tolerance is best within the range of 0.5 mA to 1.2 mA and will be electrically stimulated for 30 minutes until the patient feels "Teh Chi" "heaviness, numbness and swelling". No acupuncture procedure will be applied to the patients in the control group.Routine anesthesia and surgery will be applied. All operations will be performed by the same surgical and anesthesia team. Patients will undergo radial artery catheterization and be monitored.Anesthesia will be provided using midazolam, fentanyl and rocuronium bromide. Sevoflurane will be used as an anesthetic agent for the maintenance of general anesthesia. Rocuronium bromide (0.6 mg.kg-1) will be administered every 30 minutes. A median sternotomy will be performed on each patient.Heparin will be administered at 300-500 units kg-1 and will be neutralized with 1-1.3 mg protamine sulfate. The type and amount of cardioplegia used will be recorded. During the procedure, an activated clotting time of >400 seconds and a mean arterial pressure (MAP) of >60 mmHg will be ensured. By applying PRAM, a minimally invasive advanced hemodynamic parameters monitoring system in our study (MostCare®, Vygon, Vytech), the data we will measure will be kept within reference ranges as much as possible. Noradrenaline, dopamine, dobutamine and glyceryl trinitrate (perlinganite) will be used to maintain within these reference ranges.Hemodynamic data we will measure by applying PRAM; Dicrotic Pressure, mean arterial pressure (MAP), stroke volume, cardiac output, systemic vascular resistance (SVR), cardiac cycle efficiency, the maximal slope of systolic upstroke (dp/dtmax), arterial elastance, pulse pressure variation, stroke volume variation, values. These values will be recorded as baseline values when the patients are taken to the operating table.In additionally, These values will be recorded at 10-20-30-40-50-60 minutes after the patient has undergone sternotomy and at 10-20-30-40-50-60 minutes after the patient leaves the pump.At these times, intra-group and inter-group comparisons will be made. During these time units, hemoglobin and hematocrit values will also be recorded.These values will be tried to be kept within the normal reference range. Intraoperative inotropic agent use scores will be calculated. In addition, preoperative heart rhythm (sinus or atrial fibrillation) and postoperative heart rhythm will be recorded.BIS score will be kept between 40-50. After the surgery, each patient will be taken to the cardiovascular surgery intensive care unit.

Blood samples for measurement of troponin I, ischemic modified albumin (IMA), interleukin 6, interleukin 10 will be taken from the radial artery before aortic cross-clamping (as baseline value before sternotomy) and at 1st hour, 6th hour, 12th hour, 24th hour and after removal of the aortic cross-clamp. The fluid, blood transfusion and platelet products taken throughout the operation will be recorded. The amount of blood planned to be taken in the study was determined to be at least 5 ml each time in order to study the relevant parameters. Considering that the patient will be hemodynamically supported during coronary bypass surgery, the total amount of blood to be taken during this time period related to the study is not expected to cause any undesirable changes in the patient's hemodynamic and biochemical aspects. Postoperative data; duration of mechanical ventilation in the intensive care unit (time intubated, min), duration of stay in the intensive care unit. Postoperative complications and the development of postoperative atrial fibrillation (AF) will be recorded. Inotropic agents used at 1 hour, 6th hour, 12th hour and 24th hour in the intensive care unit will be recorded and inotropic scores will be calculated.

According to the inotropic scoring method used in this study, it will be calculated as dopamine (x1), dobutamine (x1), amrinone (x1), epinephrine (x 100) and norepinephrine (x100). Again, total chest drainage volume and urine will be monitored in the intensive care unit, and the duration of intensive care stay (days) will be recorded. Blood samples will be frozen at -70°C until the plasma, separated after centrifugation, is assayed.

Troponin I concentrations will be measured quantitatively with a one-step enzyme immunoassay (Access AccuTnI assay system; Beckman-Coulter, Fullerton, CA) by individuals blinded to group allocation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Kahramanmaraş, Turkey (Türkiye), 46040
        • Kahramanmaraş Sütçü İmam University Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification III,
  • 18-65 years old,
  • Conscious Open,
  • Participating in the study and giving permission to practice acupuncture,
  • Does not require emergency or repeat surgery,
  • Ejection/Fraction (E/F) ratio of 50-55%
  • Patients extubated within 24 hours after transfer to intensive care

Exclusion Criteria:

  • Patients who do not want to participate in the study,
  • Patients with systemic diseases such as advanced liver, kidney and lung disease,
  • Those with chronic inflammatory diseases (rheumatoid arthritis and psoriasis),
  • Patients receiving immune systemic therapy,
  • Patients with poor mental status,
  • Patients with a history of epilepsy,
  • Patients with pacemakers,
  • Patients who have had heart surgery and emergency within the last month,
  • Patients with atrial fibrillation,
  • Patients who have atrial fibrillation and cannot be measured after coming off the pump,
  • Patients who were not extubated within 24 hours after transfer to intensive care were excluded from the study.
  • Additionally, patients receiving the antidiabetic sulfonylurea or glibenclamide were excluded because these agents have been shown to abolish the cardioprotective effect elicited by ischemic preconditioning.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Active Comparator: Acupuncture group

The conductor of the study, an acupuncturist experienced in electroacupuncture, will apply electroacupuncture to the PC 6, LU7, LU2 points for 30 minutes on the day before surgery and on the day of surgery.

The placement of the needles will be applied to a depth of 1-2 cm, depending on the thickness of the local tissues, according to Traditional Chinese Medicine standards.

The EA parameter will be set to a frequency of 2 HZ/100 HZ at a current that the patients' tolerance is best within the range of 0.5 mA to 1.2 mA.

The patient will be electrically stimulated for 30 minutes until the patient feels "Teh Chi" - "heaviness, numbness and swelling".
Other: acupuncture

The insertion of the needles will be applied to a depth of 1-2 cm according to the thickness of the local tissues according to the standards of Traditional Chinese Medicine. The EA parameter will be set to a frequency of 2 HZ/100 HZ at a current that the patients' tolerance is best between 0.5 mA and 1.2 mA.

The patient will be electrically stimulated for 30 minutes until the patient feels "Teh Chi" - "heaviness, numbness and swelling".

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Troponin I
Time Frame: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
shows the myocardial injury
At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ischemic modified albumin (IMA)
Time Frame: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
IMA occurs in hypoxic heart tissue through mechanisms related to muscle damage, decreased coronary blood flow, and modification of albumin by reactive oxygen species (ROS) increased by ischemic damage.
At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Interleukin 6
Time Frame: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Interleukin 6 is an interleukin that acts as a pro-inflammatory cytokine
At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Interleukin 10
Time Frame: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Interleukin 10 is an anti-inflammatory cytokine.
At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Dicrotic pressure
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
occurs during isovolumetric relaxation
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
mean arterial pressure
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
hemodynamic parameter
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
systemic vascular resistance
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
systemic vascular resistance is the resistance that must be overcome to push blood through the circulatory system and create blood flow
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
stroke volume
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
stroke volume is the volume of blood pumped from the left ventricle per beat
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
cardiac output
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
cardiac output is the volume of blood being pumped by a single ventricle of the heart
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
dp/dtmax
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Change of left ventricular pressure over time
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Cardiac cycle efficiency
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Cardiac cycle efficiency provides a global assessment of total cardiovascular performance, measured in terms of energy expenditure.
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Arterial elastance (Ea)
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Arterial elastance is mainly related to the elasticity of the arterial system
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Pulse pressure variation (PPV)
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Dynamic fluid responsiveness parameter
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Stroke Volume Variation (SVV)
Time Frame: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Dynamic fluid responsiveness parameter
Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kahramanmaras Sutcu Imam University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yavuz Orak, Kahramanmaras Sutcu Imam University Faculty Medicine, anesthesiology and Reanimation Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 6, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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