Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT01189292
Status:
COMPLETED
Last Update Posted:
2015-07-07
First Post:
2010-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ignazio.tarantino@med.uni-heidelberg.de', 'title': 'Dr. Ignazio Tarantino', 'organization': 'Department of General, Abdominal and Transplant Surgery, University of Heidelberg'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'all patients received a bilateral superficial cervical plexus block during surgery which could explain the very low postoperative pain scores compared to other similar studies'}}, 'adverseEventsModule': {'timeFrame': 'during hospitalisation (on average 2 days)', 'description': 'adverse events were recorded during the hospital stay', 'eventGroups': [{'id': 'EG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery', 'otherNumAtRisk': 76, 'otherNumAffected': 8, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery', 'otherNumAtRisk': 76, 'otherNumAffected': 9, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'surgical adverse event grade I', 'notes': 'for example: recurrent laryngeal nerve palsy, hoarseness, minor bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien Dindo'}, {'term': 'temporary hypoparathyroidism', 'notes': 'Grade 2 on Clavien-Dindo scale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Clavien Dindo'}, {'term': 'bleeding requiring reoperation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'medical adverse events grade 1', 'notes': 'for example: coughing, sinus tachycardia, temporary compensated renal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE'}, {'term': 'Allergic reaction to metamizole', 'notes': 'CTCAE grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypocalcemia', 'notes': 'CTCAE grade 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Postoperative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'OG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '40'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '67'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28', 'ciLowerLimit': '12', 'ciUpperLimit': '42', 'groupDescription': 'null hypothesis: Incidence of PONV is the same in both treatment arms', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'within 48 hours after surgery', 'description': 'Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)\n\n* any PONV event within 48 hours after surgery\n* PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Incidence of Postoperative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'OG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '40'}, {'value': '52', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '64'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24', 'ciLowerLimit': '7', 'ciUpperLimit': '40', 'groupDescription': 'per protocol analysis', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'within 48 hours after surgery (PP)', 'description': 'Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)\n\n* any PONV event within 48 hours after surgery\n* PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol analysis'}, {'type': 'SECONDARY', 'title': 'Degree of Post Operative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'OG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}], 'classes': [{'title': 'mild nausea', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'severe nausea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'vomiting', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 hours after surgery', 'description': 'mild nausea:......single administration of an antiemetic drug\n\nsevere nausea: repeated administration of antiemetic drugs\n\nvomiting:...........at least one vomiting event', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Degree of Post Operative Nausea and Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'OG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}], 'classes': [{'title': 'mild nausea', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'severe nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'vomiting', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 hours after surgery', 'description': 'mild nausea:......single administration of an antiemetic drug\n\nsevere nausea: repeated administration of antiemetic drugs\n\nvomiting:...........at least one vomiting event', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain After Physical Stress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'OG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}], 'classes': [{'title': '4 hours after surgery', 'categories': [{'measurements': [{'value': '1.88', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '2.09', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': '8 hours after surgery', 'categories': [{'measurements': [{'value': '1.88', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '2.01', 'spread': '1.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.674', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'mixed model over the mean ranks at all time points measured (4, 8, 16, 24, 32, 48 hours)', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 and 8 hours after surgery', 'description': 'Compare grade of pain between the treatment (dexamethasone) and the control (saline) group\n\n* Pain was measured using a verbal rating scale ranging from 0 (no pain) to 10 in steps of 1\n* before obtaining the pain rating, patients were asked to turn their heads (physical stress)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat analysis'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'OG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '48.1', 'spread': '12.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.835', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Difference between day of admission and day of discharge', 'description': 'Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat'}, {'type': 'SECONDARY', 'title': 'Necessary Anesthesiological Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'OG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}], 'classes': [{'title': 'Propofol', 'categories': [{'measurements': [{'value': '1097', 'spread': '422', 'groupId': 'OG000'}, {'value': '1168', 'spread': '422', 'groupId': 'OG001'}]}]}, {'title': 'Remifentanil', 'categories': [{'measurements': [{'value': '1.944', 'spread': '1.197', 'groupId': 'OG000'}, {'value': '1.978', 'spread': '1.111', 'groupId': 'OG001'}]}]}, {'title': 'Fentanyl', 'categories': [{'measurements': [{'value': '0.427', 'spread': '0.111', 'groupId': 'OG000'}, {'value': '0.444', 'spread': '0.108', 'groupId': 'OG001'}]}]}, {'title': 'Rocuronium', 'categories': [{'measurements': [{'value': '38.7', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measured from beginning of anaesthesia to end of anaesthesia', 'description': 'Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group', 'unitOfMeasure': 'milligram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'FG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}], 'periods': [{'title': 'Intention to Treat Analysis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Per Protocol Analysis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}], 'recruitmentDetails': 'Patients older than 18 years scheduled for a primary partial or total thyroidectomy due to benign disease at the Kantonsspital St. Gallen, Department of Surgery were recruited.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexamethasone Injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)\n\nDexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery'}, {'id': 'BG001', 'title': 'Placebo (NaCl 0.9%)', 'description': 'NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.5', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '48.4', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '49.0', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '25.4', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '25.1', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diagnosis', 'classes': [{'title': 'Graves disease', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Goiter, multinodular', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}, {'title': 'Goiter, uninodular', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Type of surgery', 'classes': [{'title': 'Hemithyroidectomy', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}]}, {'title': 'Near total thyroidectomy', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Total thyroidectomy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lymph node dissection (C1/level VI)', 'classes': [{'title': 'no', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'yes', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Operating time', 'classes': [{'categories': [{'measurements': [{'value': '126.2', 'spread': '40.9', 'groupId': 'BG000'}, {'value': '127.5', 'spread': '45.7', 'groupId': 'BG001'}, {'value': '126.8', 'spread': '43.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'minutes', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Specimen weight', 'classes': [{'categories': [{'measurements': [{'value': '45.3', 'spread': '40.1', 'groupId': 'BG000'}, {'value': '51.2', 'spread': '58.2', 'groupId': 'BG001'}, {'value': '48.3', 'spread': '49.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'gram', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Histology of specimen', 'classes': [{'title': 'Papillary thyroid cancer (PTC)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Follicular thyroid cancer (FTC)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Benign disease', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-29', 'studyFirstSubmitDate': '2010-07-19', 'resultsFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2010-08-25', 'lastUpdatePostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-29', 'studyFirstPostDateStruct': {'date': '2010-08-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Postoperative Nausea and Vomiting', 'timeFrame': 'within 48 hours after surgery', 'description': 'Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)\n\n* any PONV event within 48 hours after surgery\n* PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence of Postoperative Nausea and Vomiting', 'timeFrame': 'within 48 hours after surgery (PP)', 'description': 'Compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy (primary end-point)\n\n* any PONV event within 48 hours after surgery\n* PONV was measured at 4, 8, 16, 24, 32 and 48 hours after surgery'}, {'measure': 'Degree of Post Operative Nausea and Vomiting', 'timeFrame': '4 hours after surgery', 'description': 'mild nausea:......single administration of an antiemetic drug\n\nsevere nausea: repeated administration of antiemetic drugs\n\nvomiting:...........at least one vomiting event'}, {'measure': 'Degree of Post Operative Nausea and Vomiting', 'timeFrame': '8 hours after surgery', 'description': 'mild nausea:......single administration of an antiemetic drug\n\nsevere nausea: repeated administration of antiemetic drugs\n\nvomiting:...........at least one vomiting event'}, {'measure': 'Postoperative Pain After Physical Stress', 'timeFrame': '4 and 8 hours after surgery', 'description': 'Compare grade of pain between the treatment (dexamethasone) and the control (saline) group\n\n* Pain was measured using a verbal rating scale ranging from 0 (no pain) to 10 in steps of 1\n* before obtaining the pain rating, patients were asked to turn their heads (physical stress)'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Difference between day of admission and day of discharge', 'description': 'Compare the lengths of hospital stay between the treatment (dexamethasone) and the control (saline) group'}, {'measure': 'Necessary Anesthesiological Medication', 'timeFrame': 'measured from beginning of anaesthesia to end of anaesthesia', 'description': 'Compare the amount of necessary anesthesiologic medication during the operation between the treatment (dexamethasone) and the control (saline) group'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['postoperative nausea and vomitus', 'PONV', 'thyroid surgery'], 'conditions': ['Thyroidectomy', 'Thyroid Diseases']}, 'referencesModule': {'references': [{'pmid': '25563879', 'type': 'DERIVED', 'citation': 'Tarantino I, Warschkow R, Beutner U, Kolb W, Luthi A, Luthi C, Schmied BM, Clerici T. Efficacy of a Single Preoperative Dexamethasone Dose to Prevent Nausea and Vomiting After Thyroidectomy (the tPONV Study): A Randomized, Double-blind, Placebo-controlled Clinical Trial. Ann Surg. 2015 Dec;262(6):934-40. doi: 10.1097/SLA.0000000000001112.'}, {'pmid': '24015953', 'type': 'DERIVED', 'citation': 'Tarantino I, Beutner U, Kolb W, Muller SA, Luthi C, Luthi A, Schmied BM, Clerici T, Warschkow R. Study protocol for a randomized, double-blind, placebo-controlled trial of a single preoperative steroid dose to prevent nausea and vomiting after thyroidectomy: the tPONV study. BMC Anesthesiol. 2013 Sep 9;13(1):19. doi: 10.1186/1471-2253-13-19.'}]}, 'descriptionModule': {'briefSummary': 'The study is to compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Planned partial or total thyroidectomy\n\nExclusion Criteria:\n\n* History of adverse effects to dexamethasone or propyleneglycol or di-natrium-EDTA\n* Patients with chronic pain\n* Necessity for opioids-application in the postoperative course\n* Not possible administration of a cervical block (0.5% bupivacaine at a dose of 20ml)\n* Patients with Diabetes mellitus\n* Pregnancy (test in young women)\n* Glaucoma\n* Patients who received antiemetic therapy within 48h before surgery\n* Patients with acute pain requiring painkillers others than paracetamol or more than single dose NSAR treatment within 48h before surgery\n* Use of psychotropic drugs\n* Incompliant patients\n* Preoperatively high suspicion of malignancy\n* Re-operations'}, 'identificationModule': {'nctId': 'NCT01189292', 'acronym': 'tPONV', 'briefTitle': 'Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery', 'orgStudyIdInfo': {'id': 'EKSG 10/082/2B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone injection', 'description': 'Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (NaCl 0.9%)', 'interventionNames': ['Other: NaCl 0.9%']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['Mephameson'], 'description': '8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery', 'armGroupLabels': ['Dexamethasone injection']}, {'name': 'NaCl 0.9%', 'type': 'OTHER', 'description': '2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery', 'armGroupLabels': ['Placebo (NaCl 0.9%)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Department of Surgery', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'overallOfficials': [{'name': 'Thomas Clerici, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hospital St. Gallen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D:', 'investigatorFullName': 'Ignazio Tarantino', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}