Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT03530033
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lidocaine Reduces Muscle Tremor is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D061226', 'term': 'Recurrent Laryngeal Nerve Injuries'}, {'id': 'D061227', 'term': 'Accessory Nerve Injuries'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D061224', 'term': 'Laryngeal Nerve Injuries'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D061223', 'term': 'Vagus Nerve Injuries'}, {'id': 'D020209', 'term': 'Cranial Nerve Injuries'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020436', 'term': 'Accessory Nerve Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-17', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-17', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'dose of muscle relaxant drugs', 'timeFrame': 'At the end of surgery', 'description': 'dose of muscle relaxant drugs'}, {'measure': 'dose of lidocaine', 'timeFrame': 'At the end of surgery', 'description': 'dose of lidocaine'}, {'measure': 'Number of nerve signal loss cases', 'timeFrame': 'At the end of surgery', 'description': 'Number of nerve signal loss cases'}, {'measure': 'Anatomical time of accessory nerve', 'timeFrame': 'At the end of surgery', 'description': 'Anatomical time of accessory nerve'}, {'measure': 'The satisfaction of sternocleidomastoid muscle separation', 'timeFrame': 'At the end of surgery', 'description': 'The visual score was 5 points for the most satisfaction and 0 points for the most dissatisfied.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Cancer', 'Neck Cancer', 'Recurrent Laryngeal Nerve Injuries', 'Accessory Nerve Injuries', 'EMG: Repetitive Nerve Stimulation Abnormality']}, 'descriptionModule': {'briefSummary': 'In recent years, the application of intraoperative recurrent laryngeal nerve monitoring in thyroid surgery has greatly reduced the complications of recurrent laryngeal nerve injury. The use of intraoperative neurological monitoring requires the reduction of the dose of neuromuscular blockade, which often leads to muscle tremors during the application of electrical energy, which affects the fine separation around the muscles. This study explored the effect of local application of lidocaine on reducing muscle tremor during surgery and its optimal dose.', 'detailedDescription': 'According to the random number method, eligible patients were randomly divided into 2 groups. Group A was the conventional surgery group, and Group B was the lidocaine group. The operative time for the separation of the sternocleidomastoid muscle from the two groups of patients was analyzed, as well as the length of time for the search for the accessory nerve and the effect of intraoperative nerve monitoring on the EMG signal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Thyroid papillary carcinoma\n* Lateral cervical lymph node metastasis\n* The diameter of the metastatic lymph nodes is less than 3cm\n* Without internal jugular vein invasion\n\nExclusion Criteria:\n\n* Lidocaine allergy sufferers'}, 'identificationModule': {'nctId': 'NCT03530033', 'briefTitle': 'Lidocaine Reduces Muscle Tremor is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'Lidocaine Reduces Muscle Tremor Caused by Electric Energy Devices, Which is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring During Endoscopic Thyroid Lateral Neck Dissection', 'orgStudyIdInfo': {'id': 'BND IONM Lidocaine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional surgery group', 'description': 'Induction of anesthesia according to conventional neuromuscular blockade dose, no neuromuscular blockade drug maintenance during lateral neck dissection.'}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine group', 'description': 'Anesthesia induction was performed according to conventional nerve monitoring neuromuscular blockade doses and lateral neck dissection was performed. When local muscle tremors occur, lidocaine is injected locally to eliminate muscle tremors.', 'interventionNames': ['Drug: Lidocaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Local injection of lidocaine reduces muscle tremor', 'armGroupLabels': ['Lidocaine group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350001', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'bo wang, md', 'role': 'CONTACT', 'email': 'wangbo@fjmu.edu.cn', 'phone': '13705947900'}], 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'bo wang, md', 'role': 'CONTACT', 'email': 'wangbo@fjmu.edu.cn', 'phone': '13705947900'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bo Wang,MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'clinical Professor', 'investigatorFullName': 'Bo Wang,MD', 'investigatorAffiliation': 'Fujian Medical University'}}}}