Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-28 @ 12:04 PM
Study NCT ID:
NCT01704092
Status:
UNKNOWN
Last Update Posted:
2012-10-30
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples are drawn from patients recruited into the study. We planned to draw blood samples from patients with their consent through the central line.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2013-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-26', 'studyFirstSubmitDate': '2012-10-01', 'studyFirstSubmitQcDate': '2012-10-09', 'lastUpdatePostDateStruct': {'date': '2012-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardioprective results represented by serial determination of troponin I (cTnI) cardioprective results represented by serial determination of troponin I (cTnI)', 'timeFrame': 'up to 3 days after the surgery', 'description': 'The parameter measured is dynamic so that it is needed to detect the level at different time points'}, {'measure': 'Hemodynamic values', 'timeFrame': 'from baseline to the end of the surgery', 'description': 'On the basis of our experience, the period from baseline to the end of the surgery is five hours on average and would depend on the complexity of the surgical procedure'}, {'measure': 'Serum level of β-amyloid protein', 'timeFrame': 'up to 3 days after the surgery', 'description': 'The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum. The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.'}, {'measure': 'Serum level of S100 protein', 'timeFrame': 'up to 3 days after the surgical procedure', 'description': 'The study is going to reflect the degree of central nerve system damage by detecting the level of S100 protein in serum. The serum level of S100 is preferred rather than the CSF sample because the approach of CSF sample obtaining is invasive and costly.'}], 'secondaryOutcomes': [{'measure': 'intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) and length of hospital stay (LOS)', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of4 weeks', 'description': 'The intraoperative and postoperative urine output (UO), extubation time (ET), length of stay in ICU(LOSICU ) are measured in ICU while the length of hospital stay is recorded at the discharge of every patient.'}, {'measure': 'Mini-mental state examination(MMSE) scoring', 'timeFrame': "up to patients' discharge from hospital", 'description': 'The study is planned to detect the cognitive performance with this commonly used cognitive evaluation scoring'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': "The investigators hypothesized that dexmedetomidine as an anesthetic adjunct can be used in the setting of off-pump coronary bypass procedure and can provide benefits to cardiac function and cognitive performance on the ground of the dexmedetomidine's characteristics.", 'detailedDescription': 'The emergence of off-pump coronary artery bypass grafting (OPCAB) procedure brings up new challenges to anesthesiologists and urges us to contemplate the choice of anesthetics. In face of these challenges Dexmedetomdine with multiple unique traits can readily fit into this situation.\n\nOff-pump coronary artery bypass (OPCAB) procedure is an emerging procedure which might bring benefit to patients in comparison with conventional CABGs although final words about outcomes haven\'t been reached on the basis of recent literature. However, OPCAB technique definitely requires more involvement of anesthesiologists especially in cases where hemodynamic compromise is usually inevitable during anastomosis of Lcx or PDA and early extubation in the OR is expected1. Thus, the investigators are encountered with more intraoperative challenges caused by OPCAB than routine CABGs. Concerning about challenges the investigators might take on, the investigators shall not only pay more attention to surgeons\' manipulation but also review anesthetics that the investigators have selected to find an optimal plan to minimize adverse effects on heart and other important organs. With this perspective, dexmedetomidine come into our sight with its peculiar traits of hemodynamic effects and assumed cardiac protective effects.\n\nDexmedetomidine as a more selective α2-adrenoreceptor agonist than clonidine has gradually gain popularity in anesthetic and ICU settings for its unique pharmacologic characteristics. Dexmedetomidine provides sufficient sedative effects with minimal respiratory effect and then reduces the consumption of other sedative and antinociceptive drugs.Given specific requirements of OPCAB surgery, dexmedetomidine\'s may be more suitable in varying aspects. Firstly, dexmedetomine can dramatically diminish the level of serum catecholamine (CA). As the investigators know, the diminished level of catecholamine indicates less stress response to surgical stimuli and lower incidence of cardiac events. Secondly, the relatively slower HR by dexmedetomidine can decrease oxygen consumption of myocardium and consequently improve the perfusion of endangered ischemic area. In addition, the decreased HR which is assumably analogous to effects of esmolol or other β-blockers can reduce the occurrence of tachycardia and minimize the motion of heart when "bypass" procedure is performed on the target vessels. Thirdly, it has been reported that dexmedetomidine can alleviate sufferings of renal function during major thoracic surgery .Thus, it is implied that dexmedetomidine might in the similar way ameliorate the damage to renal system caused by hours of stress response and havoc of SIRS ,and then improve clinical prognosis . In view of assumptions the investigators have proposed on the ground of dexmedetomidine\'s characteristics and specific requirements of OPCAB surgery, the investigators are expecting that dexmdetomidine can fit the situation where patients\' limited capacity of coronary artery and sophisticated pathophysiological courses have to be taken into account.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are planned to undergo off-pump coronary bypass surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) scores are between classⅡand Ⅲ\n* undergo off-pump coronary artery bypass grafting (OPCAB)\n\nExclusion Criteria:\n\n* left ventricular ejection fraction \\<40%\n* left ventricular aneurysm\n* acute myocardial infarction in latest two weeks\n* atrial fibrillation\n* associated vascular diseases\n* severe systemic diseases involving the renal and hepatic systems\n* respiratory disease( forced vital capacity less than 50% of predicted values ) preoperative left bundle branch block .'}, 'identificationModule': {'nctId': 'NCT01704092', 'briefTitle': "Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery", 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': "Dexmedetomidine's Cardiac and Cognitive Influence on Patients Undergoing Off-pump Coronary Artery Bypass Graft Surgery", 'orgStudyIdInfo': {'id': '2012001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group High-dose', 'description': 'Dexmedetomidine loading dose 1μg/kg Dexmedetomidine maintenance dose 0.6μg/kg/h', 'interventionNames': ['Drug: Dexmedetomidine']}, {'label': 'Group Low-dose', 'description': 'Dexmedetomidine loading dose 0.6μg/kg Dexmedetomidine maintenance dose 0.3μg/kg/h', 'interventionNames': ['Drug: Dexmedetomidine']}, {'label': 'Group Control', 'description': 'Dexmedetomidine loading dose and Dexmedetomidine maintenance dose were placed with the same amount of 0.9% saline as placebo', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'armGroupLabels': ['Group Control', 'Group High-dose', 'Group Low-dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology ,Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Ailin Luo, professor', 'role': 'CONTACT', 'email': 'alluo@tjh.tjmu.edu.cn', 'phone': '13507122565'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Principal Investigator, Undergraduate', 'investigatorFullName': 'Xin Chen', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}