Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2026-03-03 @ 8:19 PM
Study NCT ID:
NCT01690806
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2012-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 328}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-25', 'studyFirstSubmitDate': '2012-09-19', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2012-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Benign Neoplasm of Thyroid Gland', 'Malignant Neoplasm of Thyroid']}, 'referencesModule': {'references': [{'pmid': '23681030', 'type': 'DERIVED', 'citation': 'Schietroma M, Cecilia EM, Carlei F, Sista F, De Santis G, Lancione L, Amicucci G. Dexamethasone for the prevention of recurrent laryngeal nerve palsy and other complications after thyroid surgery: a randomized double-blind placebo-controlled trial. JAMA Otolaryngol Head Neck Surg. 2013 May;139(5):471-8. doi: 10.1001/jamaoto.2013.2821.', 'retractions': [{'pmid': '30325981', 'source': 'JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1089'}]}]}, 'descriptionModule': {'briefSummary': 'Recurrent laryngeal nerve dysfunction and hypoparathyroidism are well-recognized important complications of thyroid surgery. The duration of convalescence, after non complicated thyroid operation, may depend on several factors of which pain and fatigue are the most important. Nausea and vomiting occur mainly on the day of operation. Glucocorticoids are well known for their analgesic, anti-inflammatory, immune modulating and antiemetic effects. The investigators therefore undertook the present study to investigate whether preoperative dexamethasone could improve surgical outcome in patients undergoing thyroid surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing thyroid surgery for benign and malignant thyroidal disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing thyroid surgery\n\nExclusion Criteria:\n\n* ASA physical class III or IV\n* age \\> 75 years\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01690806', 'briefTitle': 'Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Aquila"}, 'officialTitle': 'Dexamethasone for the Prevention of Recurrent Laryngeal Nerve Palsy (and Not Only) After Thyroid Surgery. A Randomized Double-blind Placebo-controlled Trial.', 'orgStudyIdInfo': {'id': 'OTO: OTO12-0447R'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'dexamethasone', 'description': 'Patients who receive dexamethasone (8 mg; Decadron; Merck Sharp \\& Dohme) intravenously 90 min before skin incision'}, {'label': 'placebo', 'description': 'Patients who receive saline placebo intravenously 90 min before skin incision'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67100', 'city': 'L’Aquila', 'state': 'AQ', 'country': 'Italy', 'facility': 'ospedale San Salvatore-Reparto di Chirurgia Generale Universitaria', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}], 'overallOfficials': [{'name': 'Emanuela M CECILIA, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Università degli Studi dell'Aquila"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Aquila", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'CECILIA Emanuela Marina', 'investigatorAffiliation': "Università degli Studi dell'Aquila"}}}}