Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-03 @ 8:33 AM
Study NCT ID:
NCT05872451
Status:
COMPLETED
Last Update Posted:
2024-08-22
First Post:
2023-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Current Intensity for the Obturator Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients undergoing TURP procedure under general anesthesia'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2023-05-12', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial current intensity', 'timeFrame': 'About 5 minutes after starting obturator nerve block procedure', 'description': 'The current intensity for the stimulation of the obturator nerve starts at 1.0 mA (using the sequential electrical nerve stimulation mode), and the needle is advanced gradually to the location where the stimulus response occurs at 0.3-0.5 mA. After fixing the needle position in a position where contraction of the adductor longus muscle responds to the minimum current intensity, measure the current intensity.'}, {'measure': 'Final current intensity', 'timeFrame': 'About 10 minutes after starting obturator nerve block procedure', 'description': 'After administration of rocuronium (0.6 mg/kg), when the train-of-four count becomes 0, the current intensity for the stimulation of the obturator nerve is increased until the contraction of the adductor longus muscle occurs. The current intensity is measured when the contraction of the adductor longus muscle occurs.'}], 'secondaryOutcomes': [{'measure': 'Current intensity after the administration of rocuronium (0.6 mg/kg)', 'timeFrame': 'Between 5 minutes and 10 minutes after starting obturator nerve block procedure', 'description': 'After administration of rocuronium (0.6 mg/kg), the quantitative neuromuscular blockade monitoring using train-of-four is observed with 12 seconds interval. At each time point, the current intensity for the obturator nerve is increased until the contraction of the adductor longus muscle occurs. The current intensity at each time point is measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transurethral Resection of Bladder', 'Obturator Nerve', 'Nerve Block', 'Neuromuscular Blockade', 'Anesthesia, General'], 'conditions': ['Bladder Tumor']}, 'referencesModule': {'references': [{'pmid': '31842248', 'type': 'BACKGROUND', 'citation': 'Koo CH, Ryu JH. Anesthetic considerations for urologic surgeries. Korean J Anesthesiol. 2020 Apr;73(2):92-102. doi: 10.4097/kja.19437. Epub 2019 Dec 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study was to find out the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during the obturator nerve block procedure for TURP.', 'detailedDescription': 'During the transurethral resection of bladder tumors (TURBT) procedure under spinal anesthesia, the obturator nerve block is required to prevent the accidental movement of adductor longus muscles by electrical stimulation. However, during general anesthesia, the contraction of the adductor longus muscle would be lost due to deep neuromuscular blockade. However, some reports showed that the contraction of the adductor longus muscle occurs even in the deep neuromuscular blockade.\n\nThe current intensity for the nerve stimulation during nerve block is 0.3--0.5 mA when the needle tip is near the nerve. However, it is still unknown what current intensity is required to show the contraction of the adductor longus muscle when the patient is in a deep neuromuscular blockade.\n\nTherefore, in this study, investigators aimed to determine the difference in current intensity required for nerve stimulation according to the presence or absence of neuromuscular blockade during obturator nerve block for TURP. In addition, investigators aimed to determine that the obturator nerve block is required during the TURP procedure in patients with deep neuromuscular blockade during general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing TURP procedure\n\nExclusion Criteria:\n\n* Patients with anatomical or functional anomaly in the upper airways\n* Patients with neuromuscular disease\n* Patients with hip joint disorders\n* BMI of \\< 18.5 or \\> 30.0 kg/m2'}, 'identificationModule': {'nctId': 'NCT05872451', 'acronym': 'Current_ONB', 'briefTitle': 'Current Intensity for the Obturator Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'Chosun University Hospital'}, 'officialTitle': 'The Difference in the Current Intensity for the Obturator Nerve Block According to the Presence or Absence of Neuromuscular Blockage', 'orgStudyIdInfo': {'id': 'ONB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Current intensity', 'description': '1. An I-gel mask is inserted for the mechanical ventilator of the patient who is sedated with propofol.\n2. For the ultrasound-guided obturator nerve (ON) block, and needle tip gradually advanced to the anterior branch of the ON. The current intensity for the stimulation of ON starts at 1.0 mA (using the sequential electrical nerve stimulation mode), and the needle is advanced gradually to the location where the contraction of the adductor longus muscle (ALM) occurs at 0.3-0.5 mA.\n3. After fixing the needle in that position, measure the current intensity.\n4. Then, rocuronium (0.6 mg/kg) is administered under quantitative neuromuscular-blockade monitoring.\n5. When the train-of-four count becomes 0, the current intensity is increased until the contraction of the ALM occurs.\n6. The current intensity is measured when the contraction of the ALM occurs.', 'interventionNames': ['Drug: Rocuronium Bromide', 'Diagnostic Test: Nerve stimulator']}], 'interventions': [{'name': 'Rocuronium Bromide', 'type': 'DRUG', 'otherNames': ['Rocuronium'], 'description': 'After measuring the initial current intensity, quantitative neuromuscular blockade monitoring is applied, and rocuronium (0.6 mg/kg) is administered.', 'armGroupLabels': ['Current intensity']}, {'name': 'Nerve stimulator', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Stimuplex'], 'description': 'Measuring the minimum current intensity for the stimulation of the obturator nerve to show the contraction of the adductor longus muscle.', 'armGroupLabels': ['Current intensity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61453', 'city': 'Gwangju', 'country': 'South Korea', 'facility': 'Chosun University Hospital', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}], 'overallOfficials': [{'name': 'Ki Tae Jung, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Chosun University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chosun University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ki Tae Jung', 'investigatorAffiliation': 'Chosun University Hospital'}}}}