Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-13 @ 9:13 PM
Study NCT ID:
NCT02239159
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2014-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture-assisted-anesthesia to Improve Postoperative Outcome After Digestive Surgery in Elderly Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 748}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-06', 'studyFirstSubmitDate': '2014-04-06', 'studyFirstSubmitQcDate': '2014-09-10', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Pulmonary Adverse Events as a Measure of Morbidity Tolerability', 'timeFrame': 'participants will be followed from the end of the surgery to 30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Number of participants died of all causes', 'timeFrame': 'Participants will be followed from the end of the surgery to 30 days after surgery'}, {'measure': 'Length of ICU stay', 'timeFrame': 'participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days'}, {'measure': 'Number of participants with ICU admission', 'timeFrame': 'participants will be followed for the duration of hospital stay after surgery, an expected average of 7 days'}, {'measure': 'Number of participants with Systemic Inflammatory Response Syndrome(SIRS)', 'timeFrame': 'Participants will be followed from the end of the surgery to 30 days after surgery'}, {'measure': 'Length of hospital stay', 'timeFrame': 'participants will be followed for the duration of hospital stay after surgery, an expected average of 7days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['transcutaneous electric acupoint stimulation', 'elderly patients'], 'conditions': ['Postoperative Complications', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The investigators assume that transcutaneous electric acupoint stimulation (TEAS) pretreatment may activate the endogenous protective mechanism, as a result protect the patients against subsequent surgical stress pregnancy. And TEAS may induce the production of endogenous analgesic transmitters, so develop an anesthetic-sparing effect. The investigators believe this intervention will reduce the subsequent incidence, duration and severity of organ dysfunction, possibly reducing the morbidity, even mortality. So in this study, the investigators hypothesize that TEAS before anesthesia and during surgery would decrease the morbidity and mortality of postoperative complications in 30 days after digestive surgery in elderly patients .', 'detailedDescription': 'Patients older than 65 years old are at higher risk of postoperative morbidity and mortality. With the increasing number of old patients scheduled for digestive surgery, exploring methods to decrease postoperative morbidity is very important. Noninvasive methods may be easier to clinically use. Transcutaneous electric acupoint stimulation (TEAS)has been proved to decrease need for general anesthetics during anesthesia, and to alleviate systemic inflammatory response. Considering the morbidity and mortality after surgery is closely related to use of anesthetics and inflammatory response,TEAS may be a good selection for improving postoperative outcomes.Among the postoperative complications, pulmonary complication and systemic inflammatory response syndrome is with higher incidence, so we will focus on these two complications in our study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide written informed consent\n* Age ≥65 years of age\n* Elective digestive surgery under general anesthesia\n\nExclusion Criteria:\n\n* ASA(American Society of Anesthesiologists) status\\> Ⅲ\n* Patients undergoing surgery within 12 h of admission to hospital\n* Patients undergoing surgery of the chest\n* Patients suffered from neurologic disorder or impaired mental state\n* Patients with contraindications to the use of electro-acupuncture, such as skin damage or infection at the acupoints\n* Patients with experience of transcutaneous electrical stimulation treatment'}, 'identificationModule': {'nctId': 'NCT02239159', 'acronym': 'AID', 'briefTitle': 'Acupuncture-assisted-anesthesia to Improve Postoperative Outcome After Digestive Surgery in Elderly Patients', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Acupuncture-assisted-anesthesia to Improve Complications After Digestive Surgery in Elderly Patients:Multi-center Double-blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'XJH-A-2014-02-21-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Electrodes will be attached, but stimulation will not be given'}, {'type': 'SHAM_COMPARATOR', 'label': 'Non-acupoint TES', 'description': 'TES is for transcutaneous electric stimulation.Stimulation will be given through electrodes attached to non-acupoints', 'interventionNames': ['Other: TES(transcutaneous electric stimulation)']}, {'type': 'EXPERIMENTAL', 'label': 'Acupoint TES', 'description': 'Transcutaneous stimulation will be given through acupoints', 'interventionNames': ['Other: TES(transcutaneous electric stimulation)']}], 'interventions': [{'name': 'TES(transcutaneous electric stimulation)', 'type': 'OTHER', 'description': 'Stimulation will be given through electrodes attached to the skin', 'armGroupLabels': ['Acupoint TES', 'Non-acupoint TES']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital,Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Lize Xiong, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Air Force Military Medical University, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}