Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT02314234
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2014-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-23', 'studyFirstSubmitDate': '2014-12-04', 'studyFirstSubmitQcDate': '2014-12-08', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evoked EMG amplitude of facial nerve', 'timeFrame': 'up to first post-op day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Injury to Nerve During Surgery']}, 'descriptionModule': {'briefSummary': 'To investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery', 'detailedDescription': 'Intraoperative neuromonitoring (IONM) of facial nerve has been applied in identifying and preserving facial nerve during parotid surgery. In this setting, even a single dose of nondepolarizing muscle relaxant may lead to delayed and weakened electromyography (EMG) signal in facial nerve monitoring during parotid surgery. The aim of this study was to investigate the effectiveness of rapid reversal of rocuronium-induced neuromuscular block by sugammadex during IONM of facial nerve during parotid surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adult patient with facial nerve monitoring undergoing parotid surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* undergoing parotid surgery\n\nExclusion Criteria:\n\n* facial nerve injury, renal failure, liver cirrhosis, neuromuscular disease'}, 'identificationModule': {'nctId': 'NCT02314234', 'briefTitle': 'Improvement of Facial Nerve Monitoring in Parotid Surgery by Sugammadex', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'Influence of Sugammadex on Facial Nerve Monitoring in Parotid Surgery', 'orgStudyIdInfo': {'id': 'KMUH-IRB-20140248'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': 'did not receive muscle relaxant during anesthesia'}, {'label': 'Sugammadex group', 'description': 'received single dose of rocuronium for anesthesia and sugammadex at skin incision', 'interventionNames': ['Drug: sugammadex (Bridion)']}], 'interventions': [{'name': 'sugammadex (Bridion)', 'type': 'DRUG', 'description': 'single dose of sugammadex at skin incision', 'armGroupLabels': ['Sugammadex group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'I-Cheng Lu', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Visiting staff', 'investigatorFullName': 'I-Cheng Lu', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}