Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-04 @ 4:56 PM
Study NCT ID:
NCT03147066
Status:
COMPLETED
Last Update Posted:
2017-10-31
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dezocine for Prevention of Catheter-related Bladder Discomfort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C010827', 'term': 'dezocine'}, {'id': 'C504422', 'term': 'flurbiprofen axetil'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-30', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-09', 'lastUpdatePostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Catheter related bladder discomfort symptoms', 'timeFrame': 'at 1 hour after extubatio', 'description': 'CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses)'}], 'secondaryOutcomes': [{'measure': 'Catheter related bladder discomfort symptoms', 'timeFrame': 'at 0, 1, 2, and 6 hours after extubation', 'description': 'CRBD will be evaluated with a 4 point scale (1; no discomfort, 2; mild, revealed on questioning only, 3; moderate, stated by the patient without questioning, 4; severe, urinary urgency executed by behavioral responses, such as attempts to remove urinary catheter, restless extremity movements, verbal responses)'}, {'measure': 'Severity of pain at suprapubic area', 'timeFrame': 'at 0, 1, 2, and 6 hours after extubation', 'description': 'Pain at suprapubic area will be evaluated using VAS after extubation'}, {'measure': 'Sedation level', 'timeFrame': 'at 0, 1, 2, and 6 hours after extubation', 'description': 'The Ramsay Sedation Scale was measured'}, {'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': 'at 0, 1, 2, and 6 hours after extubation', 'description': 'The incidence of nausea, vomiting, hypotension, hypertension, bradycardia,respiratory depression after extubation, and excessive sedation were also recorded'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dezocine', 'CRBD', 'General anesthesia', 'Urinary catheter'], 'conditions': ['Catheter Related Bladder Discomfort']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of dezocine in preventing the catheter-related bladder discomfort (CRBD) in a postanesthesia care unit (PACU).', 'detailedDescription': "Thirty min before the end of the surgery, patients were randomly assigned to one of the two group to receive intravenous dezocine 0.1 mg/kg (Group D, n=48) or flurbiprofen axetil 1 mg/kg (Group F, n=48) . The CRBD was assessed at 0, 1, 2, and 6 h after patient's arrival in the post-anaesthesia care unit. Severity of CRBD was graded as none, mild, moderate and severe."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (\\>/=18)\n2. Male or female\n3. Patients scheduled for abdominal surgery\n4. Undergoing catheterization\n5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2\n\nExclusion Criteria:\n\n1. Patient with bladder outflow obstruction\n2. Patient with overactive bladder (frequency greater than three times per night or more than eight times per 24 h)\n3. Patient with multisystemic diseases (central nervous system, cardiovascular system hepatic, psychiatric, and end-stage renal diseases)\n4. Patient with chemical substance abuse\n5. Patient with chronic pain\n6. Patient with morbid obesity\n7. Patient needs for urgent intervention'}, 'identificationModule': {'nctId': 'NCT03147066', 'briefTitle': 'Dezocine for Prevention of Catheter-related Bladder Discomfort', 'organization': {'class': 'OTHER', 'fullName': 'Zhongda Hospital'}, 'officialTitle': 'Efficacy of Dezocine for the Prevention of Catheter-related Bladder Discomfort', 'orgStudyIdInfo': {'id': '20170110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dezocine', 'description': '0.1 mg/kg of intravenous dezocine 30 min before the end of surgery', 'interventionNames': ['Drug: Dezocine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Flurbiprofen axetil', 'description': '1 mg/kg of intravenous flurbiprofen axetil 30 min before the end of surgery', 'interventionNames': ['Drug: Flurbiprofen Axetil']}], 'interventions': [{'name': 'Dezocine', 'type': 'DRUG', 'otherNames': ['Dalgan'], 'description': 'Dezocine (0.1 mg/kg）will be infused during surgery', 'armGroupLabels': ['Dezocine']}, {'name': 'Flurbiprofen Axetil', 'type': 'DRUG', 'description': 'Flurbiprofen Axetil (1 mg/kg）will be infused during surgery', 'armGroupLabels': ['Flurbiprofen axetil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210009', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Zhongda Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Jian-jun Yang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongda Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jian-jun Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Department of Anesthesiology', 'investigatorFullName': 'Jian-jun Yang', 'investigatorAffiliation': 'Zhongda Hospital'}}}}