Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-25 @ 11:01 PM
Study NCT ID:
NCT00569920
Status:
COMPLETED
Last Update Posted:
2009-01-15
First Post:
2007-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nausea and Pain Prophylaxis During Thyroid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C018038', 'term': 'dexamethasone acetate'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-14', 'studyFirstSubmitDate': '2007-12-07', 'studyFirstSubmitQcDate': '2007-12-07', 'lastUpdatePostDateStruct': {'date': '2009-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (VAS) and use of opioids. Nausea.', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Nausea', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Thyroid Diseases', 'Parathyroid Diseases']}, 'descriptionModule': {'briefSummary': "Postoperative pain and nausea may diminish a patient's wellbeing, and may also delay rehabilitation, as well as increase the total cost of care and treatment. Opioids are effective drugs for treatment of pain, but with the disadvantage of side effects such as somnolence and nausea. The benefits of various types of non-opioid analgesic in reducing patients' postoperative need for opioids have been well-documented.\n\nOne non-opioid prophylaxis documented for various surgery is short-term treatment with corticosteroids. The optimal dose of corticosteroids for peroperative nausea and pain prophylaxis is not well-documented. In our study we will attempt to determine whether the aforementioned benefits of corticosteroids are valid for a group of patients undergoing thyroid surgery.\n\nHypothesis: Single-dose treatment with dexamethasone provides a better analgesic effect and/or reduced use of opioids than placebo in patients undergoing elective throid surgery. Higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without influencing the side effect profile."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inpatients scheduled for elective thyroid surgery and parathyroid surgery under general anesthesia.\n* Informed consent\n\nExclusion Criteria:\n\n* Patients who use steroids\n* Patients who use antiemetics\n* Patients who use opioid analgesics\n* Body weight \\> 100 kg\n* BMI \\> 35'}, 'identificationModule': {'nctId': 'NCT00569920', 'briefTitle': 'Nausea and Pain Prophylaxis During Thyroid Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sykehuset Telemark'}, 'officialTitle': 'Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo', 'orgStudyIdInfo': {'id': 's8197.04'}, 'secondaryIdInfos': [{'id': 'S-04189'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: natriumchloride 0,9%']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'dexamethasone "low-dose"', 'interventionNames': ['Drug: dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Dexamethasone "high-dose"', 'interventionNames': ['Drug: dexamethasone']}], 'interventions': [{'name': 'dexamethasone', 'type': 'DRUG', 'otherNames': ['Fortecortin'], 'description': 'IV dexamethasone 0,15 mg/kg bodyweight. Single-dose bolus injection after start of anesthesia. Medication is opened and administrated to the patient from a coded ampoule by the physician. The medication is diluted in such a way that 1 mL is equivalent to 10 kg body weight (1,5 mg/mL).', 'armGroupLabels': ['2']}, {'name': 'natriumchloride 0,9%', 'type': 'DRUG', 'description': 'iv natriumchloride 0,9% (placebo). 1 mL is equivalent to 10 kg body weight.', 'armGroupLabels': ['1']}, {'name': 'dexamethasone', 'type': 'DRUG', 'otherNames': ['fortecortin'], 'description': 'IV dexamethasone 0,30 mg/kg body weight. Drug diluted to 3,0 mg/mL and administrated in same way as arm 2.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3919', 'city': 'Porsgrunn', 'state': 'Telemark', 'country': 'Norway', 'facility': 'Surgery Unit, Porsgrunn, Acute Care Clinic, Telemark Hospital', 'geoPoint': {'lat': 59.14054, 'lon': 9.6561}}], 'overallOfficials': [{'name': 'Johan Raeder, Prof. M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ullevål university hospital, Oslo university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sykehuset Telemark', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Simen Doksrød/Acting chief physician', 'oldOrganization': 'Sykehuset Telemark'}}}}