Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-31 @ 5:37 PM
Study NCT ID:
NCT03632460
Status:
UNKNOWN
Last Update Posted:
2018-08-15
First Post:
2018-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2018-08-14', 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in postoperative pain level using visual analogue scale', 'timeFrame': 'Before operation, 1 hour, 2 hour, 6 hour and 24 hour after operation', 'description': 'Change in baseline postoperative pain level measured before operation, and then at 1h, 2h, 6h and 24h after operation using visual analogue scale. Visual analogue scale is numerical scale in range from 1-10, assessing pain level. Minimum score is 1, which represents- no pain to maximum score 10 which represents- the worst pain ever experienced.'}], 'secondaryOutcomes': [{'measure': 'analgesic consumption', 'timeFrame': '24 hour', 'description': 'analgesic consumption in time interval'}, {'measure': 'oxydative stress level', 'timeFrame': '24 hour', 'description': 'malonyldialdehyde, glutathion, catalase'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative', 'Oxidative Stress']}, 'referencesModule': {'references': [{'pmid': '28924366', 'type': 'RESULT', 'citation': 'Kim NY, Kwon TD, Bai SJ, Noh SH, Hong JH, Lee H, Lee KY. Effects of dexmedetomidine in combination with fentanyl-based intravenous patient-controlled analgesia on pain attenuation after open gastrectomy in comparison with conventional thoracic epidural and fentanyl-based intravenous patient-controlled analgesia. Int J Med Sci. 2017 Aug 18;14(10):951-960. doi: 10.7150/ijms.20347. eCollection 2017.'}, {'pmid': '28535549', 'type': 'RESULT', 'citation': 'Hong JM, Kim KH, Lee HJ, Kwon JY, Kim HK, Kim HJ, Cho AR, Do WS, Kim HS. Epidural Dexamethasone Influences Postoperative Analgesia after Major Abdominal Surgery. Pain Physician. 2017 May;20(4):261-269.'}, {'pmid': '29325842', 'type': 'RESULT', 'citation': 'Gallego-Ligorit L, Vives M, Valles-Torres J, Sanjuan-Villarreal TA, Pajares A, Iglesias M. Use of Dexmedetomidine in Cardiothoracic and Vascular Anesthesia. J Cardiothorac Vasc Anesth. 2018 Jun;32(3):1426-1438. doi: 10.1053/j.jvca.2017.11.044. Epub 2017 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery', 'detailedDescription': 'The aim of the study is to investigate the effect of preoperative epidural dexmedetomidine compared to dexamethasone on postoperative pain control, analgesic consumption and oxydative stress response in patients undergoing thoracic surgery.\n\nInvestigation will include patients between 30-70 years undergoing thoracic surgery due to malignant process of lung or oesophagus.\n\nPatients are divided in two groups: epidural administration of 0.375% ropivacaine with 1 mcg/kg dexmedetomidine (group 1) and epidural administration of 0.375% ropivacaine with 8 mg dexamethasone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing thoracic surgery due to malignant process of lung or oesophagus ASA (American Society of Anesthesiologists) status I-III\n\nExclusion Criteria:\n\n* neurological or psychiatric disease\n* corticosteroid therapy\n* anamnesis of myocardial infarct within last 6 months\n* severe aortic stenosis\n* kidney insufficiency\n* liver insufficiency\n* allergy\n* coagulation disorders'}, 'identificationModule': {'nctId': 'NCT03632460', 'briefTitle': 'Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine in Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Dubrava'}, 'officialTitle': 'Comparison of Epidural Dexmedetomidine and Dexamethasone as an Adjuvant to Ropivacaine on Postoperative Pain Level, Analgesic Consumption and Oxidative Stress in Thoracic Surgery', 'orgStudyIdInfo': {'id': 'UHDubrava777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dexmedetomidine', 'description': '1 mcg/kg dexmedetomidine added to 8 ml 0.375% ropivacaine', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dexamethasone', 'description': '8 mg dexamethasone added to 8 ml 0,375% ropivacaine', 'interventionNames': ['Drug: Dexmedetomidine Injection [Precedex]']}], 'interventions': [{'name': 'Dexmedetomidine Injection [Precedex]', 'type': 'DRUG', 'description': 'epidural administration of dexmedetomidine added to ropivacaine', 'armGroupLabels': ['Dexamethasone', 'Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'contacts': [{'name': 'Andrej Sribar, MD', 'role': 'CONTACT', 'email': 'jasminka@kbd.hr', 'phone': '+38512902433', 'phoneExt': '+38512902433'}, {'name': 'Jasminka Persec', 'role': 'CONTACT', 'email': 'jasminka@kbd.hr', 'phone': '+38512902433', 'phoneExt': '+38512902433'}], 'facility': 'Jasminka Persec', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}], 'centralContacts': [{'name': 'Jasminka Persec, Assist Prof', 'role': 'CONTACT', 'email': 'jasminka@kbd.hr', 'phone': '+385 1 2902433', 'phoneExt': '+38512902440'}, {'name': 'Andrej Sribar, MD PhD', 'role': 'CONTACT', 'email': 'andrej.sribar@gmail.com', 'phone': '+385 1 2902440', 'phoneExt': '+38512902440'}], 'overallOfficials': [{'name': 'Jasminka Persec, Assit Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Dubrava'}, {'name': 'Andrej Sribar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Dubrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Dubrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist Prof MD PhD', 'investigatorFullName': 'Jasminka Persec, MD, PhD', 'investigatorAffiliation': 'University Hospital Dubrava'}}}}