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
2 other identifiers
interventional
315
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2014
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedStudy Start
First participant enrolled
October 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedMarch 9, 2023
March 1, 2023
11 months
August 18, 2014
March 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Dosage of sufentanil used during anesthesia
Dosage of sufentanil used during anesthesia
during the anesthesia
Secondary Outcomes (12)
Evaluation of inotropic scores
24h postoperatively
Dosage of propofol used during anesthesia
During the anesthesia
Time of mechanical ventilation
at 30 days
In-hospital stay
at 30 days
Incidence of overall complication
at 30 days
- +7 more secondary outcomes
Study Arms (3)
distal-proximal group
EXPERIMENTALTEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu"
regional group
ACTIVE COMPARATORTEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque"
control group
SHAM COMPARATORno TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" .
Interventions
transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Hegu" before anesthesia in distal-proximal group
transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists I-III
- Scheduled for Off-Pump Coronary-Artery Bypass Grafting surgery
- First thoracotomy
- Signed written informed consent obtained
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Li ze Xiong, M.D.,Ph.D.
Xijing Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD& PhD
Study Record Dates
First Submitted
August 18, 2014
First Posted
May 13, 2015
Study Start
October 16, 2017
Primary Completion
September 6, 2018
Study Completion
October 31, 2020
Last Updated
March 9, 2023
Record last verified: 2023-03