Electroacupuncture in Reducing the Dose of Analgesic in Patients Undergoing Off-pump Coronary Artery Bypass Grafting

NCT ID: NCT02443220

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2020-10-31

Brief Summary

A prospective, multiple-center, double-blinded, randomized, controlled clinical study to evaluate the antalgic effects between distal-proximal acupoints combination and regional acupoints combination stimulated with electroacupuncture on patients undergoing Off-Pump Coronary-Artery Bypass Grafting(OP-CABG).This clinical trial is to investigate whether electroacupuncture(EA) anesthesia can reduce analgesic in OP-CABG surgery in distal-proximal group.The origins of therapeutic acupuncture can be traced back at least 2,500 years in China. There has been an explosion of interest in Western medicine within the United States and Europe in application of acupuncture technique. Acupuncture enjoys worldwide acceptance for treating diseases such as migraine, chronic low back pain, and knee osteoarthritis. In 2002, WHO recommended 107 symptoms, syndromes, and diseases definitively shown to be effectively treated by acupuncture. Coronary heart disease (angina pectoris) is among these pathologies. A recent clinical trial demonstrated an acupuncture-assisted anesthesia strategy reduces postoperative morbidity and medical costs in open-heart surgery under cardiopulmonary bypass. Previous researches in animal models have demonstrated that electroacupuncture pretreatment protects the heart from ischemic injury. The investigators observed that electroacupuncture pretreatment (EAP, 30-minute electric stimulation through 4 electrodes attached to the bilateral forearm acupoints) before surgery significantly attenuated serum troponin levels during and shortly post-surgery in adult heart valve replacement patients and children undergoing cardiac surgery correcting congenital heart malformation.However, whether electroacupuncture anesthesia may reduce analgesic in OP-CABG surgery,especially in different combination of acupoints,has never been previously investigated.

Detailed Description

The anesthesia will be performed in a standard way. The propofol and sufentanil will be infused in target-controlled infusion mode. The dosage of analgesic will be assessed by the consumption of sufentanil. And the electroacupuncture anesthesia will be implemented by a device named "Hua Tuo" electronic acupuncture treatment instrument.

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

distal-proximal group

TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu"

Group Type: EXPERIMENTAL

TEAS (transcutaneous electric acupoint stimulation)

Intervention Type: DEVICE

transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Hegu" before anesthesia in distal-proximal group

regional group

TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque"

Group Type: ACTIVE_COMPARATOR

TEAS

Intervention Type: DEVICE

transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group

control group

no TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" .

Group Type: SHAM_COMPARATOR

TEAS

Intervention Type: DEVICE

The device will be connected to "Danzhong" and "Hegu" but no stimulation to the acupoints 30 min before anesthesia

Interventions

TEAS (transcutaneous electric acupoint stimulation)

transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Hegu" before anesthesia in distal-proximal group

Intervention Type: DEVICE

TEAS

transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group

Intervention Type: DEVICE

TEAS

The device will be connected to "Danzhong" and "Hegu" but no stimulation to the acupoints 30 min before anesthesia

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists I-III
• Scheduled for Off-Pump Coronary-Artery Bypass Grafting surgery
• First thoracotomy
• Signed written informed consent obtained

Exclusion Criteria

• American Society of Anesthesiologists IV
• Undergoing surgery within 12 h of admission to hospital
• Life expectancy < 1 year at the time of enrollment
• Hemodynamic instability as defined by a systolic blood pressure <90 mmHg
• Preoperative Intra-aortic Balloon Pumping or Ventricular Assisted Device
• Severe hepatic or renal dysfunction
• Not the first thoracotomy
• Mediastinal fiber thickening or severe pleural adhesions
• Severe adverse reactions
• Severe systemic infection
• With contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints
• Suffering from nervous system disease or abnormal mental state
• Participate in the other clinical trial 3 month before the enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chong Lei, MD & phD

MD& PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li ze Xiong, M.D.,Ph.D.

Role: STUDY_CHAIR

Xijing Hospital

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

81370011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KY20140420-X-1

Identifier Type: -

Identifier Source: org_study_id