Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-07-16 @ 5:54 PM
Study NCT ID:
NCT02443220
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2014-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroacupuncture in Reducing the Dose of Analgesic in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-06', 'studyFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2015-05-09', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosage of sufentanil used during anesthesia', 'timeFrame': 'during the anesthesia', 'description': 'Dosage of sufentanil used during anesthesia'}], 'secondaryOutcomes': [{'measure': 'Evaluation of inotropic scores', 'timeFrame': '24h postoperatively', 'description': 'inotropic drugs used postoperatively'}, {'measure': 'Dosage of propofol used during anesthesia', 'timeFrame': 'During the anesthesia', 'description': 'Dosage of propofol used during anesthesia'}, {'measure': 'Time of mechanical ventilation', 'timeFrame': 'at 30 days', 'description': 'length of mechanical ventilation postoperatively'}, {'measure': 'In-hospital stay', 'timeFrame': 'at 30 days', 'description': 'It is the length of hospital stay postoperatively'}, {'measure': 'Incidence of overall complication', 'timeFrame': 'at 30 days', 'description': 'Incidence of overall complication postoperatively'}, {'measure': 'Incidence of overall mortality', 'timeFrame': 'at 30 days', 'description': 'Incidence of overall mortality postoperatively'}, {'measure': 'The length of CCU stay', 'timeFrame': 'at 30 days', 'description': 'Length of CCU stay postoperatively'}, {'measure': 'Heart rate during the anesthesia', 'timeFrame': 'during the anesthesia', 'description': 'Heart rate during the anesthesia'}, {'measure': 'Mean arterial pressure during the anesthesia', 'timeFrame': 'during the anesthesia', 'description': 'Mean arterial pressure during the anesthesia'}, {'measure': 'Bispectral index during the anesthesia', 'timeFrame': 'during the anesthesia', 'description': 'Bispectral index during the anesthesia'}, {'measure': 'Incidence of overall complication', 'timeFrame': 'at 1 year', 'description': 'Incidence of overall complications postoperatively'}, {'measure': 'Incidence of overall mortality', 'timeFrame': 'at 1 year', 'description': 'Incidence of overall mortality postoperatively'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists I-III\n* Scheduled for Off-Pump Coronary-Artery Bypass Grafting surgery\n* First thoracotomy\n* Signed written informed consent obtained\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists IV\n* Undergoing surgery within 12 h of admission to hospital\n* Life expectancy \\< 1 year at the time of enrollment\n* Hemodynamic instability as defined by a systolic blood pressure \\<90 mmHg\n* Preoperative Intra-aortic Balloon Pumping or Ventricular Assisted Device\n* Severe hepatic or renal dysfunction\n* Not the first thoracotomy\n* Mediastinal fiber thickening or severe pleural adhesions\n* Severe adverse reactions\n* Severe systemic infection\n* With contraindications to the use of electroacupuncture, such as skin damage or infection at the acupoints\n* Suffering from nervous system disease or abnormal mental state\n* Participate in the other clinical trial 3 month before the enrollment'}, 'identificationModule': {'nctId': 'NCT02443220', 'briefTitle': 'Electroacupuncture in Reducing the Dose of Analgesic in Patients Undergoing Off-pump Coronary Artery Bypass Grafting', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Effects of Regional and Distant Combination of Acupoints Stimulated With Electroacupuncture on Patients Undergoing Off-pump Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'KY20140420-X-1'}, 'secondaryIdInfos': [{'id': '81370011', 'type': 'OTHER_GRANT', 'domain': 'National nature and science foundation of China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'distal-proximal group', 'description': 'TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu"', 'interventionNames': ['Device: TEAS (transcutaneous electric acupoint stimulation)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'regional group', 'description': 'TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Juque"', 'interventionNames': ['Device: TEAS']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'no TEAS (transcutaneous electric acupoint stimulation) on "Danzhong" and "Hegu" .', 'interventionNames': ['Device: TEAS']}], 'interventions': [{'name': 'TEAS (transcutaneous electric acupoint stimulation)', 'type': 'DEVICE', 'description': 'transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Hegu" before anesthesia in distal-proximal group', 'armGroupLabels': ['distal-proximal group']}, {'name': 'TEAS', 'type': 'DEVICE', 'description': 'transcutaneous electric acupoint will commence at 30 min on "Danzhong" and "Juque" before anesthesia in regional group', 'armGroupLabels': ['regional group']}, {'name': 'TEAS', 'type': 'DEVICE', 'description': 'The device will be connected to "Danzhong" and "Hegu" but no stimulation to the acupoints 30 min before anesthesia', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Li ze Xiong, M.D.,Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Xijing Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD& PhD', 'investigatorFullName': 'Chong Lei, MD & phD', 'investigatorAffiliation': 'Xijing Hospital'}}}}