Skip to main content
OpenTrials
Completed

NCT Number: NCT02443220

Electroacupuncture in Reducing the Dose of Analgesic in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEAS (transcutaneous electric acupoint stimulation)

Device

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

TEAS

Device

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

Primary outcomes

  1. Dosage of sufentanil used during anesthesia

    Time frame: during the anesthesia

    Dosage of sufentanil used during anesthesia

Secondary outcomes

  1. Evaluation of inotropic scores

    Time frame: 24h postoperatively

    inotropic drugs used postoperatively

  2. Dosage of propofol used during anesthesia

    Time frame: During the anesthesia

    Dosage of propofol used during anesthesia

  3. Time of mechanical ventilation

    Time frame: at 30 days

    length of mechanical ventilation postoperatively

  4. In-hospital stay

    Time frame: at 30 days

    It is the length of hospital stay postoperatively

  5. Incidence of overall complication

    Time frame: at 30 days

    Incidence of overall complication postoperatively

  6. Incidence of overall mortality

    Time frame: at 30 days

    Incidence of overall mortality postoperatively

  7. The length of CCU stay

    Time frame: at 30 days

    Length of CCU stay postoperatively

  8. Heart rate during the anesthesia

    Time frame: during the anesthesia

    Heart rate during the anesthesia

  9. Mean arterial pressure during the anesthesia

    Time frame: during the anesthesia

    Mean arterial pressure during the anesthesia

  10. Bispectral index during the anesthesia

    Time frame: during the anesthesia

    Bispectral index during the anesthesia

  11. Incidence of overall complication

    Time frame: at 1 year

    Incidence of overall complications postoperatively

  12. Incidence of overall mortality

    Time frame: at 1 year

    Incidence of overall mortality postoperatively

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
May 13, 2015
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.