Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2026-02-26 @ 6:28 AM
Study NCT ID:
NCT05396716
Status:
UNKNOWN
Last Update Posted:
2022-05-31
First Post:
2022-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D014839', 'term': 'Vomiting'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The stimulator is put in an opaque box'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-25', 'studyFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2022-05-25', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of nausea and vomiting by 24 hours after surgery', 'timeFrame': 'from end of surgery to 24 hours after surgery, in a total of 24 hours'}], 'secondaryOutcomes': [{'measure': 'incidence of nausea and vomiting by 48 hours after surgery', 'timeFrame': 'from end of surgery to 48 hours after surgery, in a total of 48 hours'}, {'measure': 'incidence of nausea and vomiting in PACU (post-anesthesia care unit)', 'timeFrame': 'from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes'}, {'measure': 'score of nausea and vomiting by 24 hours after surgery', 'timeFrame': 'from end of surgery to 24 hours after surgery, in a total of 24 hours'}, {'measure': 'score of nausea and vomiting by 48 hours after surgery', 'timeFrame': 'from end of surgery to 48 hours after surgery, in a total of 48 hours'}, {'measure': 'score of nausea and vomiting in PACU(post-anesthesia care unit)', 'timeFrame': 'from end of surgery to discharge from PACU, in an average of 30 minutes'}, {'measure': 'Quality of recovery score at 24 hours after surgery', 'timeFrame': 'from end of surgery to 24 hours after surgery, in a total of 24 hours'}, {'measure': 'Quality of recovery score at 48 hours after surgery', 'timeFrame': 'from end of surgery to 48 hours after surgery, in a total of 48 hours'}, {'measure': 'postoperative in-hospital stay', 'timeFrame': 'from end of surgery to discharge from hospital, in an average of 7 days'}, {'measure': 'death by 6 months after surgery', 'timeFrame': 'from end of surgery to 6 months after surgery, in a total of 6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcutaneous electrical acupoint stimulation', 'liver surgery'], 'conditions': ['PONV']}, 'referencesModule': {'references': [{'pmid': '26522652', 'type': 'BACKGROUND', 'citation': 'Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.'}]}, 'descriptionModule': {'briefSummary': 'Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥18 years\n* scheduled for elective liver surgery under general anesthesia\n\nExclusion Criteria:\n\n* body mass index less than 18 kg/m2 or higher than 30 kg/m2\n* American Society of Anesthesiologists status higher than Ⅲ\n* patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device\n* suspected or existed abuse of drug or alcohol\n* pregnant or breeding women\n* history of neurological or psychiatric disease'}, 'identificationModule': {'nctId': 'NCT05396716', 'briefTitle': 'Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Nausea and Vomiting After Liver Surgery', 'orgStudyIdInfo': {'id': 'XJH-A-20220410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'transcutaneous electrical acupoint stimulation', 'interventionNames': ['Device: transcutaneous electrical acupoint stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'transcutaneous electrical acupoint stimulation', 'type': 'DEVICE', 'otherNames': ['TEAS'], 'description': 'Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.', 'armGroupLabels': ['transcutaneous electrical acupoint stimulation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhihong Lu', 'role': 'CONTACT', 'email': 'deerlu23@163.com', 'phone': '+8613891975018'}, {'name': 'Shan He', 'role': 'CONTACT', 'email': '1411950442@qq.com', 'phone': '8684775343'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhihong LU', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}