Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-29 @ 11:01 PM
Study NCT ID:
NCT00888303
Status:
UNKNOWN
Last Update Posted:
2012-09-05
First Post:
2009-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D013965', 'term': 'Thyroidectomy'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-01', 'studyFirstSubmitDate': '2009-04-23', 'studyFirstSubmitQcDate': '2009-04-24', 'lastUpdatePostDateStruct': {'date': '2012-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative nausea and vomit (PONV) measured in 4 grades', 'timeFrame': '8, 24, 32 and 48 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain after thyroidectomy measured in a 0-100 Visual analog scale', 'timeFrame': '8, 24, 32 and 48 hours after surgery'}, {'measure': 'Vocal function measured in a 0-100 Visual analog scale', 'timeFrame': '8, 24, 32 and 48 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Postoperative Nausea and Vomit', 'Postoperative Vocal Function', 'Thyroidectomy']}, 'referencesModule': {'references': [{'pmid': '19092351', 'type': 'RESULT', 'citation': 'Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of 8 mg of dexamethasone administered prior surgery, to reduce pain, postoperative nausea and vomiting and to improve vocal function after thyroidectomy for benign disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Patients undergoing thyroidectomy\n\nExclusion Criteria:\n\n* Patients who had received antiemetic therapy within 48 hours before surgery\n* Patients with depression\n* Chronic pain disorder\n* Insulin-dependent diabetes mellitus\n* History of severe and/or repeated PONV after previous minor surgery, that led to change from standard anesthetic protocol\n* Pregnancy\n* Age \\< 18 years\n* Patients who had known malignant disease or had undergone previous thyroid or neck surgery'}, 'identificationModule': {'nctId': 'NCT00888303', 'briefTitle': 'Single Dose Steroid Before Thyroidectomy for Benign Disease to Improve Postoperative Nausea, Pain, and Vocal Function', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Misericordia e Dolce'}, 'officialTitle': 'Randomized Controlled Trial on Efficacy of Preemptive 8 mg of Dexamethasone for Reducing Pain and Postoperative Nausea and Vomit After Thyroidectomy for Benign Disease.', 'orgStudyIdInfo': {'id': 'MD123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A (dexamethasone)', 'description': '20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered', 'interventionNames': ['Drug: Dexamethasone', 'Procedure: Thyroidectomy, total or partial']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B (Control)', 'description': '20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous', 'interventionNames': ['Drug: saline solution', 'Procedure: Thyroidectomy, total or partial']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': '20 minutes before total or partial thyroidectomy for benign disease a single dose of intravenous 8 mg/2mL of dexamethasone is administered', 'armGroupLabels': ['A (dexamethasone)']}, {'name': 'saline solution', 'type': 'DRUG', 'description': '20 minutes before total or partial thyroidectomy for benign disease 100 mg of saline solutions are administered intravenous', 'armGroupLabels': ['B (Control)']}, {'name': 'Thyroidectomy, total or partial', 'type': 'PROCEDURE', 'description': 'Surgical standard intervention', 'armGroupLabels': ['A (dexamethasone)', 'B (Control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Prato', 'state': 'Po', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Feroci, MD', 'role': 'CONTACT', 'email': 'fferoci@yahoo.it', 'phone': '+393389592375'}, {'name': 'Francesco Feroci, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andrea Borrelli, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Misericordia and Dolce Hodpital', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}], 'centralContacts': [{'name': 'Francesco Feroci, MD', 'role': 'CONTACT', 'email': 'fferoci@yahoo.it', 'phone': '+393398382381'}, {'name': 'Marco Scatizzi, MD', 'role': 'CONTACT', 'email': 'marco.scatizzi@usl4.toscana.it', 'phone': '+39574434647'}], 'overallOfficials': [{'name': 'Marco Scatizzi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Misericordia and Dolce Hospital'}, {'name': 'Marco Rettori, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Misericordia and Dolce Hospital'}, {'name': 'Francesco Feroci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Misericordia and Dolce Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Misericordia e Dolce', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md', 'investigatorFullName': 'Marco Scatizzi', 'investigatorAffiliation': 'Ospedale Misericordia e Dolce'}}}}