Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT05272033
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2022-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, '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': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patients blood pressure will be measured', 'timeFrame': '30 minutes following spinal anesthesia', 'description': 'Hypotension was defined as a preoperative systolic measurement of \\>20% or a systolic blood pressure below 100 mmHg.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypotension']}, 'descriptionModule': {'briefSummary': 'Despite prophylactic measures, hypotension remains a common side-effect of spinal anesthesia. Electroacupuncture influences hemodynamics. We hypothesized that transcutaneous electrical acupuncture point stimulation (TEAS) at traditionally used acupuncture points would reduce the severity of hypotension after spinal anesthesia in geriatric patients undergoing hernia surgery.', 'detailedDescription': 'After obtaining written informed patient consent, 60 geriatric patients undergoing hernia surgery under spinal anesthesia were randomized into two groups. In the placebo TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation. The acupoint group will receive TEAS at the PC-5, PC-6, and ST-36 points bilaterally before the spinal anesthesia. The spinal anesthesia will be performed using 12.5 mg 0.5% bupivacaine was from the L3-4 or L4-5 interval with a 25G Quincke spinal needle. Hemodynamic data will be followed every five minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III patients aged 65 years and older who are scheduled for inguinal hernia repair\n\nExclusion Criteria:\n\n* Patients with neurological or psychological diseases\n* Patients who have been treated with TEAS or acupuncture before,\n* Patients with heart failure and pace-maker\n* Those who have a local infection in the TEAS area.'}, 'identificationModule': {'nctId': 'NCT05272033', 'briefTitle': 'Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Konya Meram State Hospital'}, 'officialTitle': 'The Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Prevention Hypotension Related to Spinal Anesthesia in Elderly Patients', 'orgStudyIdInfo': {'id': 'TEAS Elderly Hypotension'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP TEAS', 'description': 'Patients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at PC-5, PC-6, and ST-36 with an electronic acupuncture device.', 'interventionNames': ['Device: Transcutaneous Electrical Acupoint Stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham TEAS', 'description': 'In the sham TEAS group, the gel electrodes will be applied at the same anatomical points without stimulation.', 'interventionNames': ['Device: Transcutaneous Electrical Acupoint Stimulation']}], 'interventions': [{'name': 'Transcutaneous Electrical Acupoint Stimulation', 'type': 'DEVICE', 'description': 'Transcutaneous Electrical Acupoint Stimulation', 'armGroupLabels': ['GROUP TEAS', 'Sham TEAS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42005', 'city': 'Konya', 'country': 'Turkey (Türkiye)', 'facility': 'Betul Kozanhan', 'geoPoint': {'lat': 37.87135, 'lon': 32.48464}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Meram State Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass.Prof.', 'investigatorFullName': 'Betul Kozanhan', 'investigatorAffiliation': 'Konya Meram State Hospital'}}}}