Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-03-03 @ 3:54 PM
Study NCT ID:
NCT03163693
Status:
UNKNOWN
Last Update Posted:
2017-05-23
First Post:
2017-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Dexmedetomidine on cTnI and GP-BB in Patients Undergoing OPCABG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C567654', 'term': 'Cardiomyopathy, Dilated, 1FF'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-20', 'studyFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2017-05-20', 'lastUpdatePostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of cardiac troponin I at preoperative, postoperative，and 24 hours after surgery.', 'timeFrame': 'At preoperative, postoperative，and 24 hours after surgery.', 'description': 'Blood samples were sampled at preoperative, postoperative，and 24 hours after surgery for the cTnI，which were analyzed by using enzyme linked immunosorbent assay (ELISA).'}, {'measure': 'Change of Glycogen Phosphorylase Isoenzyme BB at preoperative, postoperative，and 24 hours after surgery.', 'timeFrame': 'At preoperative, postoperative，and 24 hours after surgery.', 'description': 'Blood samples were sampled at preoperative, postoperative，and 24 hours after surgery for the GP-BB，which were analyzed by using enzyme linked immunosorbent assay (ELISA).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dexmedetomidine', 'Cardiac Troponin I', 'Glycogen Phosphorylase Isoenzyme BB'], 'conditions': ['Coronary Artery Bypass, Off-Pump']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients undergoing off-pump coronary artery bypass Grafting.', 'detailedDescription': 'Dexmedetomidine is a highly selective α2-adrenoceptor agonist used as a sedative or adjuvant anesthetic drug in clinical settings.From clinical observation, dexmedetomidine has been revealed to reduce the incidence of cardiovascular adverse events in patients with heart diseases during non-cardiac surgeries.Therefore, the aim of this sudy is to observe the impact of dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in patients during cardiac surgeries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing off - pump coronary artery bypass grafting\n* ASA physical status III-IV\n* Aged 40-70 years\n* NYHA physical status II-III\n\nExclusion Criteria:\n\n* Bradycardia\n* Atrioventricular block\n* Echocardiography suggested:LVEF \\<40%, LVED\\>65mm\n* Allergic to the drugs'}, 'identificationModule': {'nctId': 'NCT03163693', 'briefTitle': 'The Effects of Dexmedetomidine on cTnI and GP-BB in Patients Undergoing OPCABG', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Ningxia Medical University'}, 'officialTitle': 'The Effects of Dexmedetomidine on Cardiac Troponin I and Glycogen Phosphorylase Isoenzyme BB in Patients Undergoing Off-pump Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': '2015-NW-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group dexmedetomidine', 'description': '20 eligible patients are received 0.5ug/kg dexmedetomidine intravenously 15 minutes before surgery', 'interventionNames': ['Drug: dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group control', 'description': '20 eligible patients are received equal volumes normal saline intravenously 15 minutes before surgery', 'interventionNames': ['Other: normal saline']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Dex'], 'description': 'receive dexmedetomidine 0.5 μg/kg', 'armGroupLabels': ['Group dexmedetomidine']}, {'name': 'normal saline', 'type': 'OTHER', 'description': 'receive equal volume of normal saline', 'armGroupLabels': ['Group control']}]}, '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': 'Zhu Di', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Ningxia Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'safety'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Ningxia Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}