Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-05 @ 5:19 PM
Study NCT ID:
NCT03634956
Status:
UNKNOWN
Last Update Posted:
2018-08-20
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014826', 'term': 'Vocal Cord Paralysis'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D020421', 'term': 'Vagus Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Group A. Sugammadex sodium-IONM in thyroid surgery Group B.Standart technique-IONM in thyroid surgery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-03-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2018-08-13', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vocal cord paralysis', 'timeFrame': 'postop 15th days', 'description': 'postoperative vocal cord examination will be performed and the recurrent laryngeal nerve will be examined.'}], 'secondaryOutcomes': [{'measure': 'vagal nerve conduction value(V1)', 'timeFrame': '15 to 45 minutes of surgery', 'description': 'V1: value to receive enough nerve conduction for IONM use from the vagus nerve'}, {'measure': 'vagal nerve conduction value after lob resection(V2)', 'timeFrame': '30 to 90 minutes of surgery', 'description': 'V2:Vagus value after resection of thyroid lobe'}, {'measure': 'first detected vagal nerve conduction value(V0)', 'timeFrame': '5 to 25 minutes of surgery', 'description': 'initial value after vagus sinus is detected'}, {'measure': 'TOF time', 'timeFrame': '10 to 90 minutes of surgery', 'description': 'the time that the muscle relaxant is shown by the peripheral nerve stimulator whose effect has disappeared.TOF\\>0.9'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multinoduler goitre', 'thyroid cancer', 'sugammadex sodium', 'intraoperative nerve monitorization'], 'conditions': ['Vocal Cord Paralysis', 'Recurrent Laryngeal Nerve']}, 'referencesModule': {'references': [{'pmid': '28349321', 'type': 'BACKGROUND', 'citation': 'Empis de Vendin O, Schmartz D, Brunaud L, Fuchs-Buder T. Recurrent Laryngeal Nerve Monitoring and Rocuronium: A Selective Sugammadex Reversal Protocol. World J Surg. 2017 Sep;41(9):2298-2303. doi: 10.1007/s00268-017-4004-9.'}, {'pmid': '19177420', 'type': 'BACKGROUND', 'citation': 'Barczynski M, Konturek A, Cichon S. Randomized clinical trial of visualization versus neuromonitoring of recurrent laryngeal nerves during thyroidectomy. Br J Surg. 2009 Mar;96(3):240-6. doi: 10.1002/bjs.6417.'}]}, 'descriptionModule': {'briefSummary': "Thyroidectomy is a frequently performed surgeon by the head and neck and endocrine surgeons. In recent years, surgical techniques and technological developments have resulted in a significant reduction in complication rates. Despite these advances, there is still a great deal of anxiety about the sound problems that can be experienced in patients after surgery. In the past years,the investigators have tried to prevent recurrent nerve paralysis by using intraoperative nerve monitoring (IONM). The use of IONM has begun to be preferred by many surgeons in the investigator's country. However, the use of IONM decreases the number of recurrent nerve paralysis are still being discussed and many studies have been done. In this study, it is aimed to prevent the formation of recurrent nerve paralysis in order to safely carry out the IONM by removing the effects of neuromuscular blockade drugs using sugammadex sodium medicine in the thyroidectomy operations.", 'detailedDescription': 'Patients who will undergo thyroidectomy using the IONM in the General Surgery Clinic of Istanbul, Bakırköy Dr.Sadi Konuk Training and Research Hospital. In this prospective observational clinical trial, the patients will be divided into two groups and the study will be performed as randomize. Randomization Patients who arrive consecutively, will be included in the study group (Group I IONM, group B IONM-sugammadex sodium). In both groups, anesthesia induction should be done with 3 mg / kg propofol, 2 ugr / kg fentanyl, 0.6 mg / kg rocuronium bromide, as the intubation tube, the number appropriate for the patient, After reaching the throat loom, the patient is entrapped and then the operation is started. After reaching the thyroid loin and hanging the throid with the swab sutures, the lobe is taken out with the finger maneuver and then the vascular nerve packet is dissected and the vagal nerve is exposed. IONM(Medtronic-NIM) were detected in the recurrent nerve thyroglossal groove and 100 microvolts or more were measured with nerve monitoring. + Acceptance of resection was started and IONM After the intubation of the group B-sugammadex sodium was started, the left hand ulnar sinus TOF-Guard device was placed and operation started. After reaching the thyroid loops and hanging the throids with hanging sutures and removing the lobe with finger maneuver, the vascular nerve was disassembled and the vagal nerve was dislocated. Then the electrical value was recorded with IONM and sugammadex sodium 2 mg / kg was made. and the TOF response at 4th minute is over 90% of the value to be measured and if the IONM is 100 microvolts higher, the recurrent nerve is found in the troglossal groove and the nerve is followed with the IONM and the resection procedure is started and the tirodidectomy will be performed. V0: vagal nerve initial value; V1: value before troid resection; V2: value after troid resection; R1: value after troid resection, R2: value after troid resection. Preoperative and postoperative vocal cord examination will be examined by otolaryngologist. Size, weight, sex, ASA scores, operation times, complications will be recorded. If there is no signal in RLN with intraoperative IONM and RLN paralysis will be accepted if there is inactivity in the vocal cord at the 1st postoperative ENT specialist vocal cord examinations. RLN paralysis will be accepted if there is inactivity in the cord at the vocal cord examination of the postoperative specialist ENT specialist. The ENT specialist and general surgeon will follow up and if the vocal cord is still in motion, the permanent RLN will be considered a paralysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Multinodular goiter,\n* Clinical diagnosis of thyroid cancer\n* Clinical diagnosis of noduler goatr,\n* Clinical diagnosis of basedow Graves disease,\n\nExclusion Criteria:\n\n* Patients with bleeding diathesis,\n* Patients who have previously undergone laryngeal surgery (vocal polyps, nodules or laryngeal cancer),'}, 'identificationModule': {'nctId': 'NCT03634956', 'briefTitle': 'Effect of IONM on Efficacy and Safety Using Sugammadex in Thyroid Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lütfiye Nuri Burat Government Hospital'}, 'officialTitle': 'Reversal of Rocuronium-Induced Neuromuscular Blockade by Sugammadex Increase for Efficiency of Intraoperative Neural Monitoring in the Thyroid Surgery', 'orgStudyIdInfo': {'id': 'BakirköyEAH 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I.IONM in thyroid surgery', 'description': 'Group I.IONM in thyroid surgery.Once the vagus has been detected,nerve conduction data will be detected with IONM. If the muscle relaxant effect is not detected, it will be detected with TOF device.', 'interventionNames': ['Drug: Group B. Sugammadex sodium-IONM']}], 'interventions': [{'name': 'Group B. Sugammadex sodium-IONM', 'type': 'DRUG', 'otherNames': ['Sugammadex sodium intervention group'], 'description': 'Group B.the vagal nerve is detected and then 2 mg / kg of sugammadex sodium is administered to remove the muscle relaxant effect', 'armGroupLabels': ['Group I.IONM in thyroid surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34300', 'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Turgut Donmez, MD', 'role': 'CONTACT', 'email': 'surgeont73@hotmail.com', 'phone': '00905347400967'}], 'facility': 'Lutfiye NBGH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Turgut Donmez, surgeon', 'role': 'CONTACT', 'email': 'surgeont73@hotmail.com', 'phone': '+905347400967'}, {'name': 'Mehmet Emin Gunes, surgeon', 'role': 'CONTACT', 'email': 'memgunes@hotmail.com', 'phone': '+90532 59943334'}], 'overallOfficials': [{'name': 'Turgut Donmez, surgeon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lütfiye Nuri Burat Goverment Hastanesi'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '14.08.2018-14.02.2019', 'ipdSharing': 'YES', 'description': "Patients who are accepted to participate in the study will be gathered in the pool. The patients' data will be entered on the computer. The computer and patients will be randomized and set up on the day of surgery. The preop, perop and postop data of the patients will be recorded on the computer.", 'accessCriteria': "the study data will be stored securely on the researcher's turgut donmez personal computer. It will be available to researchers participating in the study alone"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lütfiye Nuri Burat Government Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'TURGUT DONMEZ', 'investigatorAffiliation': 'Lütfiye Nuri Burat Government Hospital'}}}}