Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-02 @ 3:16 PM
Study NCT ID:
NCT06754995
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2024-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Feasibility of 100 Hz Tetanic Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D055191', 'term': 'Delayed Emergence from Anesthesia'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-23', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '60 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG', 'timeFrame': 'From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.', 'description': 'Electroneurography response of the abductor digiti minimi muscle to 60 Hz tetanic stimulation (tetanic fade) is examined to find out if there is difference in patients with or without polyneuropathy. Tetanic fade is the decrease of the twitch heights of the compound muscle action potential due to depletion of cetylcholin stores in the nerve terminal during tetanic stimulation.'}], 'primaryOutcomes': [{'measure': '100 Hz tetanic fade response of abductor digiti minimi muscle to ulnar nerve stimulation in patients with normal and abnormal ENG', 'timeFrame': 'From enrollment until end of anesthesia asessed up to 1 hour. No further ENG measurements are performed in the postoperative period.', 'description': 'Electroneurography response of the abductor digiti minimi muscle to 100 Hz tetanic stimulation (tetanic fade) is examined to find out if there is difference in patients with or without polyneuropathy. Tetanic fade is the decrease of the twitch heights of the compound muscle action potential due to depletion of cetylcholin stores in the nerve terminal during tetanic stimulation.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic feasibility of electromyography in the examination of safety margin', 'timeFrame': 'From enrollment until end of anesthesia assessed up to 1 hour. No further ENG measurements are performed in the postoperative period.', 'description': 'To see whether tetanic stimulation with electromyography can be used as a routine tool to examine the safety margin and residual neuromuscular block. It is expected that there will be no fade in muscle response to 60 Hz tetanic stimulation in either groups. It is suspected that there will be no tetanic fade response to 100 Hz tetanic stimulation in patinets with normal ENG, however patinets with abnormal baseline ENG will produce tetanic fade. The incidence and extent of tetanic fade response will be examined.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electromyography', 'electroneurography', 'tetanic stimulation', 'residual neuromuscular block', 'neuromuscular monitoring'], 'conditions': ['Polyneuropathies']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography device in the exclusion of postoperative residual neuromuscular block. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings.', 'detailedDescription': 'The aim of the present study is to investigate the applicability of 100 Hz tetanic stimulation with an electromyography (EMG) device. The aim is to determine whether fatigue develops with 100 Hz tetanic stimulation in anaesthetized, non-relaxed patients with normal or abnormal baseline electroneurographic (ENG) findings. Electric responses of the musculus digiti minimi elicited by supramaximal stimulation of the ulnar nerve at the carpal tunnel are monitored. Alpine Biomed ENG-EMG device with Keypoint software version 5.11 is used for the examinations. The exposed arm is fixed on the armboard, the skin is degreased and then the electrodes for monitoring are mounted lege artis. After the anesthesia has been induced, ENG of the ulnar nerve is examined. Based on the results of the ENG test, patients are divided into separate groups (normal or abnormal ENG). During the ENG test, the supramaximal current is determined. Afterwards, repetitive tetanic stimulation of the defined frequency (60 and 100 Hz) and duration (5 sec) is applied to the two test groups at the current according to the test plan.\n\nThe clinical utilities of the study results are:\n\n* Determination of the "safety margin" of neuromuscular junction, which is not provided by routine monitoring.\n* To investigate how comorbid status (especially chronic conditions affecting peripheral nerves such as polyneuropathy) influences the feasibility of tetanic stimulation in the diagnostics of residual neuromuscular block and safety margin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1-3;\n* BMI 18.5-25 (normal body weight);\n* patient is in supine position with one arm accessible.\n\nExclusion Criteria:\n\n* diseases with impaired neuromuscular function (myopathies, severe liver and kidney failure);\n* drugs affecting neuromuscular function (magnesium, aminoglycosides);\n* pregnancy (pregnancy tests are carried out in women of childbearing age to rule out pregnancy);\n* breast-feeding;\n* acute surgery'}, 'identificationModule': {'nctId': 'NCT06754995', 'briefTitle': 'Diagnostic Feasibility of 100 Hz Tetanic Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Debrecen'}, 'officialTitle': 'Diagnostic Feasibility of 100 Hz Tetanic Stimulation in the Perioperative Setting in Patients With Normal and Abnormal ENG: a Pilot Study', 'orgStudyIdInfo': {'id': 'AITT 2024/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal ENG', 'description': 'Patients who have normal results at baseline electroneurogrphy examination'}, {'label': 'Abnormal ENG', 'description': 'Patients who have abnormal results at baseline electroneurogrphy examination due to polyneuropathy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4032', 'city': 'Debrecen', 'state': 'Hajdú-Bihar', 'status': 'NOT_YET_RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Adrienn Pongrácz, MD PhD', 'role': 'CONTACT', 'email': 'pongadri@gmail.com', 'phone': '+36302390132'}, {'name': 'Réka Nemes, MD PhD', 'role': 'CONTACT', 'email': 'reka.nemes.11@gmail.com', 'phone': '+36309668722'}, {'name': 'Mariann Fedor, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adrienn Pongrácz, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Réka Nemes, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'László Asztalos, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology and Intensive Care, University of Debrecen', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '4032', 'city': 'Debrecen', 'status': 'RECRUITING', 'country': 'Hungary', 'facility': 'University of Debrecen Medical Center, Department of Anesthesiology and Intensive Care', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}], 'centralContacts': [{'name': 'Adrienn Pongrácz, MD PhD', 'role': 'CONTACT', 'email': 'pongadri@gmail.com', 'phone': '+36302390132'}, {'name': 'Réka Nemes, MD PhD', 'role': 'CONTACT', 'email': 'reka.nemes.11@gmail.com', 'phone': '+36309668722'}], 'overallOfficials': [{'name': 'Béla Fülesdi, MD PhD DSci', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Debrecen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Debrecen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Pongrácz Adrienn', 'investigatorAffiliation': 'University of Debrecen'}}}}