Protective Effects of Acupuncture in Cardiac SurgeryNCT06110780
Investigation of the Effectiveness of Electroacupuncture in Patients Undergoing Coronary Artery Bypass Surgery.
A study testing acupuncture in people with Protective Effects of Acupuncture in Cardiac Surgery, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Protective Effects of Acupuncture in Cardiac Surgery
- What is being tested?
- acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2024to 6 Mar 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University Faculty of Medicine
Kahramanmaraş, 46040
About this study
Official title: 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.
Read the 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.
- Being tested
- acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
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".
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Active comparator | 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". Receives: Other: acupuncture |
| Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin I
shows the myocardial injury
Measured: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Secondary outcomes (13)
Ischemic modified albumin (IMA)
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.
Measured: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Interleukin 6
Interleukin 6 is an interleukin that acts as a pro-inflammatory cytokine
Measured: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Interleukin 10
Interleukin 10 is an anti-inflammatory cytokine.
Measured: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,
Dicrotic pressure
occurs during isovolumetric relaxation
Measured: 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
hemodynamic parameter
Measured: 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
systemic vascular resistance is the resistance that must be overcome to push blood through the circulatory system and create blood flow
Measured: 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
stroke volume is the volume of blood pumped from the left ventricle per beat
Measured: 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
cardiac output is the volume of blood being pumped by a single ventricle of the heart
Measured: 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
Change of left ventricular pressure over time
Measured: 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
Cardiac cycle efficiency provides a global assessment of total cardiovascular performance, measured in terms of energy expenditure.
Measured: 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)
Arterial elastance is mainly related to the elasticity of the arterial system
Measured: 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)
Dynamic fluid responsiveness parameter
Measured: 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)
Dynamic fluid responsiveness parameter
Measured: Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start8 Feb 2024
- Primary completion1 Feb 2025
- Study completion6 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protective Effects of Acupuncture in Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Orak, Kahramanmaras Sutcu Imam University
- Investigators
- Yavuz Orak, Principal investigator, Kahramanmaras Sutcu Imam University Faculty Medicine, anesthesiology and Reanimation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110780
- Sponsor's protocol ID
- 2022/01
- Status last verified
- Sep 2025
- First submitted
- 26 Oct 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Hemodynamic, Cardioprotective and Anti-inflammatory Effectiveness of Electroacupuncture in Patients Undergoing Coronary Artery Bypass Surgery: Randomized, Controlled Study.
- ClinicalTrials.gov ID
- NCT06110780
- Acronym / sponsor ID
- 2022/01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 8 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 6 Mar 2025 (actual)
- First posted
- 1 Nov 2023 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Active comparator | Other: acupunctureThe 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". |
| Control group | No intervention | –Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (12 listed)
- 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,
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 |
|---|---|---|
| acupunctureThe 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". | Other | Acupuncture group |
Primary outcome
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
13 secondary outcomes
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,
Interleukin 6
Time frame: 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,
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
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
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
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
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
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
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
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
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
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
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 18 Sep 2025.
- Individual participant dataSharing planned: No
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.
Yavuz Orak principal investigator
Kahramanmaras Sutcu Imam University Faculty Medicine, anesthesiology and Reanimation Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Protective Effects of Acupuncture in Cardiac Surgery, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
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 7 inclusion and 12 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 18 Sep 2025. 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 Turkey (Türkiye). 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. 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?
Troponin I (time frame: At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.