Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:47 PM
Study NCT ID:
NCT04943367
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2021-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of TEAS on Rocuronium Injection Pain
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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-05', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-06-27', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain with rocuronium injection', 'timeFrame': '5 minutes', 'description': 'pain will be graded as no pain; mild pain; moderate pain; severe pain following administration of a priming dose of rocuronium'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Injection Pain']}, 'descriptionModule': {'briefSummary': 'Pain from the injection of rocuronium is a common side effect during anesthetic practice, occurring in 50%-80% of patients. Several methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing the rocuronium injection pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-65 year aged\n* ASA I-III\n* Who was to undergo various elective operations.\n\nExclusion Criteria:\n\n* Cardiovascular surgery\n* Patients with pacemakers\n* Patients requiring rapid sequential induction'}, 'identificationModule': {'nctId': 'NCT04943367', 'briefTitle': 'Effect of TEAS on Rocuronium Injection Pain', 'organization': {'class': 'OTHER', 'fullName': 'Konya Meram State Hospital'}, 'officialTitle': 'Efficacy of TEAS On Prevention of Rocuronium Injection Pain', 'orgStudyIdInfo': {'id': 'Rocuronium injection pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'GROUP TEAS', 'description': 'Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6).', 'interventionNames': ['Device: TEAS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Sham Group', 'description': 'Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation.', 'interventionNames': ['Device: TEAS']}], 'interventions': [{'name': 'TEAS', 'type': 'DEVICE', 'description': 'Transcutaneous electrical acupuncture stimulation', 'armGroupLabels': ['Control Sham Group', 'GROUP 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'}}}}