Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-09 @ 12:20 PM
Study NCT ID:
NCT02314650
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2014-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEAS to Reduce Propofol Consumption During General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2014-12-07', 'studyFirstSubmitQcDate': '2014-12-09', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'propofol consumption', 'timeFrame': 'from induction to the end of surgery,at an average of 1 hour'}], 'secondaryOutcomes': [{'measure': 'time to awake', 'timeFrame': 'from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes'}, {'measure': 'time to extubation', 'timeFrame': 'from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes'}, {'measure': 'effect site concentration of propofol at awake', 'timeFrame': 'from end of propofol infusion to open eyes to verbal command,at an average of 30 minutes'}, {'measure': 'highest sedation score during stay at postanesthesia care unit', 'timeFrame': 'from end of surgery to discharge from post anesthesia care unit, at an average of 1 hour'}, {'measure': 'nausea and vomiting during stay at postanesthesia care unit', 'timeFrame': '30min after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '12598279', 'type': 'RESULT', 'citation': 'Fassoulaki A, Paraskeva A, Patris K, Pourgiezi T, Kostopanagiotou G. Pressure applied on the extra 1 acupuncture point reduces bispectral index values and stress in volunteers. Anesth Analg. 2003 Mar;96(3):885-890. doi: 10.1213/01.ANE.0000048713.41657.D3.'}, {'pmid': '18356793', 'type': 'RESULT', 'citation': 'Nayak S, Wenstone R, Jones A, Nolan J, Strong A, Carson J. Surface electrostimulation of acupuncture points for sedation of critically ill patients in the intensive care unit--a pilot study. Acupunct Med. 2008 Mar;26(1):1-7. doi: 10.1136/aim.26.1.1.'}]}, 'descriptionModule': {'briefSummary': 'The study is aimed at whether transcutaneous electrical acupoint stimulation (TEAS) during general anesthesia could reduce the need for propofol in patients undergoing minor surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing minor surgeries including laparoscopic surgery and breast surgery under general anesthesia\n* Patients with written informed consent\n\nExclusion Criteria:\n\n* Patients with difficulty to communicate,including psychiatric disorder and Alzheimer's disease\n* Patients with drug abuse\n* Patients with disease of central nervous system\n* Patients with renal or hepatic dysfunction"}, 'identificationModule': {'nctId': 'NCT02314650', 'acronym': 'TOP', 'briefTitle': 'TEAS to Reduce Propofol Consumption During General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'Effect of Transcutaneous Electrical Acupoint Stimulation on Propofol Consumption During General Anesthesia', 'orgStudyIdInfo': {'id': 'XJH-A-2014-6-25-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous acupoint stimulation', 'description': 'Electrical stimulation was given through electrodes attached to skin at Ximen and Shenmen acupoint during anesthesia', 'interventionNames': ['Other: acupoint stimulation', 'Other: electrodes attached']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-acupoint stimulation', 'description': 'Electrical stimulation was given through electrodes attached to skin at shoulder (non-acupoint) during anesthesia', 'interventionNames': ['Other: non-acupoint stimulation', 'Other: electrodes attached']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'patients were with electrodes attached but no stimulation was given', 'interventionNames': ['Other: electrodes attached']}], 'interventions': [{'name': 'acupoint stimulation', 'type': 'OTHER', 'description': 'stimulation was given at acupoints', 'armGroupLabels': ['Transcutaneous acupoint stimulation']}, {'name': 'non-acupoint stimulation', 'type': 'OTHER', 'description': 'stimulation was given at non-acupoints', 'armGroupLabels': ['Non-acupoint stimulation']}, {'name': 'electrodes attached', 'type': 'OTHER', 'description': 'electrode were attached to skin', 'armGroupLabels': ['Control', 'Non-acupoint stimulation', 'Transcutaneous acupoint stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'Xijing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Zhihong LU, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', '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'}}}}