Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-22 @ 7:23 AM
Study NCT ID:
NCT02768168
Status:
COMPLETED
Last Update Posted:
2016-08-03
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-11-14', 'releaseDate': '2016-09-26'}], 'estimatedResultsFirstSubmitDate': '2016-09-26'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010827', 'term': 'dezocine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-02', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2016-08-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The duration of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)', 'timeFrame': 'In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate'}], 'primaryOutcomes': [{'measure': 'The occurrence of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)', 'timeFrame': 'In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate'}], 'secondaryOutcomes': [{'measure': 'The severity of perineal irritation after the injection of dexamethasone 21-phosphate among Group D (40 patients receive dezocine 0.1 mg/Kg) and Group C (40 patients receive matching placebo)', 'timeFrame': 'In the first 3 min period after the injection of dexamethasone 21-phosphate phosphate'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dezocine', 'Dexamethasone 21-phosphate', 'Pain', 'Pruritus'], 'conditions': ['Adverse Effect']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy of dezocine pretreatment on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).', 'detailedDescription': 'Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. Some patients undergo spontaneous remission, while others develop into severe pain or pruritus. Dezocine, a new synthetic opiate agonist-antagonist, has been used for the treatment of pain and pruritus, but its role in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dezocine pretreatment on dexamethasone induced perineal irritation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-65 years\n* ASA physical status I-II\n* BMI 18-24.5 kg/m2\n\nExclusion Criteria:\n\n* On regular use of analgesic\n* Contraindication or allergy to steroid or dezocine\n* Drug or alcohol abuse\n* Diagnosed with paresthesia or mental diseases\n* Communication disorders\n* Pregnancy or nursing'}, 'identificationModule': {'nctId': 'NCT02768168', 'briefTitle': 'The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'The Effects of Dezocine Pretreatment on Dexamethasone Induced Perineal Irritation', 'orgStudyIdInfo': {'id': 'mz2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group D', 'description': '40 patients receive dezocine 0.1 mg/Kg', 'interventionNames': ['Drug: dezocine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group C', 'description': '40 patients receive matching placebo （normal saline）', 'interventionNames': ['Other: normal saline']}], 'interventions': [{'name': 'dezocine', 'type': 'DRUG', 'description': 'receive dezocine 0.1 mg/kg', 'armGroupLabels': ['Group D']}, {'name': 'normal saline', 'type': 'OTHER', 'description': 'receive matching placebo (equal volume of normal saline)', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '750004', 'city': 'Yinchuan', 'state': 'Ningxia', 'country': 'China', 'facility': 'General Hospital of Ningxia Medical University', 'geoPoint': {'lat': 38.46806, 'lon': 106.27306}}], 'overallOfficials': [{'name': 'Junwei Zheng', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Ningxia Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-09-26', 'type': 'RELEASE'}, {'date': '2016-11-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'General Hospital of Ningxia Medical University'}}}}