Coronary DiseaseNCT02443220
Electroacupuncture in Reducing the Dose of Analgesic in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
A study testing TEAS (transcutaneous electric acupoint stimulation) and TEAS in people with Coronary Disease, run by Xijing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- TEAS (transcutaneous electric acupoint stimulation) and TEAS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2017to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists I-III
- Scheduled for Off-Pump Coronary-Artery Bypass Grafting surgery
- First thoracotomy
- Signed written informed consent obtained
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- TEAS (transcutaneous electric acupoint stimulation), TEAS
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAS (transcutaneous electric acupoint stimulation)Device
transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Hegu" before anesthesia in distal-proximal group
TEASDevice
transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group
TEASDevice
The device will be connected to "Danzhong" and "Hegu" but no stimulation to the acupoints 30 min before anesthesia
| Study group | Role | What they receive |
|---|---|---|
| distal-proximal group | Experimental | TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" Receives: Device: TEAS (transcutaneous electric acupoint stimulation) |
| regional group | Active comparator | TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque" Receives: Device: TEAS |
| control group | Sham comparator | no TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" . Receives: Device: TEAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of sufentanil used during anesthesia
Dosage of sufentanil used during anesthesia
Measured: during the anesthesia
Secondary outcomes (12)
Evaluation of inotropic scores
inotropic drugs used postoperatively
Measured: 24h postoperatively
Dosage of propofol used during anesthesia
Dosage of propofol used during anesthesia
Measured: During the anesthesia
Time of mechanical ventilation
length of mechanical ventilation postoperatively
Measured: at 30 days
In-hospital stay
It is the length of hospital stay postoperatively
Measured: at 30 days
Incidence of overall complication
Incidence of overall complication postoperatively
Measured: at 30 days
Incidence of overall mortality
Incidence of overall mortality postoperatively
Measured: at 30 days
The length of CCU stay
Length of CCU stay postoperatively
Measured: at 30 days
Heart rate during the anesthesia
Heart rate during the anesthesia
Measured: during the anesthesia
Mean arterial pressure during the anesthesia
Mean arterial pressure during the anesthesia
Measured: during the anesthesia
Bispectral index during the anesthesia
Bispectral index during the anesthesia
Measured: during the anesthesia
Incidence of overall complication
Incidence of overall complications postoperatively
Measured: at 1 year
Incidence of overall mortality
Incidence of overall mortality postoperatively
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start16 Oct 2017
- Primary completion6 Sep 2018
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Lei, MD & phD, Xijing Hospital
- Investigators
- Li ze Xiong, M.D.,Ph.D., Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443220
- Sponsor's protocol ID
- KY20140420-X-1
- Other IDs
- 81370011
- Status last verified
- Mar 2023
- First submitted
- 18 Aug 2014
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Regional and Distant Combination of Acupoints Stimulated With Electroacupuncture on Patients Undergoing Off-pump Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT02443220
- Acronym / sponsor ID
- KY20140420-X-1
- Conditions
- Coronary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| distal-proximal group | Experimental | Device: TEAS (transcutaneous electric acupoint stimulation)TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" |
| regional group | Active comparator | Device: TEASTEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque" |
| control group | Sham comparator | Device: TEASno TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists I-III
- Scheduled for Off-Pump Coronary-Artery Bypass Grafting surgery
- First thoracotomy
- Signed written informed consent obtained
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAS (transcutaneous electric acupoint stimulation)transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Hegu" before anesthesia in distal-proximal group | Device | distal-proximal group |
| TEAStranscutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group | Device | regional group |
| TEASThe device will be connected to "Danzhong" and "Hegu" but no stimulation to the acupoints 30 min before anesthesia | Device | control group |
Primary outcome
Dosage of sufentanil used during anesthesia
Time frame: during the anesthesia
Dosage of sufentanil used during anesthesia
12 secondary outcomes
Evaluation of inotropic scores
Time frame: 24h postoperatively
Dosage of propofol used during anesthesia
Time frame: During the anesthesia
Time of mechanical ventilation
Time frame: at 30 days
In-hospital stay
Time frame: at 30 days
Incidence of overall complication
Time frame: at 30 days
Incidence of overall mortality
Time frame: at 30 days
The length of CCU stay
Time frame: at 30 days
Heart rate during the anesthesia
Time frame: during the anesthesia
Mean arterial pressure during the anesthesia
Time frame: during the anesthesia
Bispectral index during the anesthesia
Time frame: during the anesthesia
Incidence of overall complication
Time frame: at 1 year
Incidence of overall mortality
Time frame: at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li ze Xiong, M.D.,Ph.D. study chair
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS (transcutaneous electric acupoint stimulation) and TEAS in people with Coronary Disease, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of sufentanil used during anesthesia (time frame: during the anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.