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

Effects of Regional and Distant Combination of Acupoints Stimulated With Electroacupuncture on Patients Undergoing Off-pump Coronary Artery Bypass Grafting

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.

Study Overview

• Status: Completed
• Conditions: Coronary Disease
• Intervention / Treatment: Device: TEAS (transcutaneous electric acupoint stimulation); Device: TEAS; Device: TEAS

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.

• Study Type: Interventional
• Enrollment (Actual): 315
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: distal-proximal group; TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu"	Device: TEAS (transcutaneous electric acupoint stimulation); transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Hegu" before anesthesia in distal-proximal group
Active Comparator: regional group; TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque"	Device: TEAS; transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group; Device: TEAS; The device will be connected to "Danzhong" and "Hegu" but no stimulation to the acupoints 30 min before anesthesia
Sham Comparator: control group; no TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" .	Device: TEAS; transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group; Device: TEAS; The device will be connected to "Danzhong" and "Hegu" but no stimulation to the acupoints 30 min before anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosage of sufentanil used during anesthesia	Dosage of sufentanil used during anesthesia	during the anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of inotropic scores	inotropic drugs used postoperatively	24h postoperatively
Dosage of propofol used during anesthesia	Dosage of propofol used during anesthesia	During the anesthesia
Time of mechanical ventilation	length of mechanical ventilation postoperatively	at 30 days
In-hospital stay	It is the length of hospital stay postoperatively	at 30 days
Incidence of overall complication	Incidence of overall complication postoperatively	at 30 days
Incidence of overall mortality	Incidence of overall mortality postoperatively	at 30 days
The length of CCU stay	Length of CCU stay postoperatively	at 30 days
Heart rate during the anesthesia	Heart rate during the anesthesia	during the anesthesia
Mean arterial pressure during the anesthesia	Mean arterial pressure during the anesthesia	during the anesthesia
Bispectral index during the anesthesia	Bispectral index during the anesthesia	during the anesthesia
Incidence of overall complication	Incidence of overall complications postoperatively	at 1 year
Incidence of overall mortality	Incidence of overall mortality postoperatively	at 1 year

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Li ze Xiong, M.D.,Ph.D., Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Actual): September 6, 2018
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: August 18, 2014
• First Submitted That Met QC Criteria: May 9, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: KY20140420-X-1; 81370011 (Other Grant/Funding Number: National nature and science foundation of China)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No