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

NCT06110780 | Completed

• 1 other identifier: 2022/01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Protective Effects of Acupuncture in Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Troponin I

  shows the myocardial injury

  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)

  At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,

• Interleukin 6

  At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,

• Interleukin 10

  At baseline levels, 1st hour, 6th hour, 12th hour, 24th hour changes after removal of the aortic cross-clamp,

• Dicrotic pressure

  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

  Baseline changes after sternotomy at 10, 20, 30, 40, 50, 60 minutes and pump discontinuation at 10, 20, 30, 40, 50, 60 minutes

Study Arms (2)

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".

Other: acupuncture

Control group

NO INTERVENTION

Control group

Interventions

acupuncture OTHER

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".

Acupuncture group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification III,
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaras Sutcu Imam University Faculty of Medicine

Kahramanmaraş, 46040, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yavuz Orak

  Kahramanmaras Sutcu Imam University Faculty Medicine, anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: February 8, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 6, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)