Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-27 @ 5:38 PM
Study NCT ID:
NCT02393066
Status:
COMPLETED
Last Update Posted:
2015-08-05
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal 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': 'D015742', 'term': 'Propofol'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2014-10-27', 'studyFirstSubmitQcDate': '2015-03-15', 'lastUpdatePostDateStruct': {'date': '2015-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac index', 'timeFrame': 'six hours after recruitment', 'description': 'the cardiac index measured by the Bioreactance-based noninvasive CO measurement (NICOM system) six hours after recruitment'}], 'secondaryOutcomes': [{'measure': 'mean arterial pressure', 'timeFrame': 'six hours after recruitment'}, {'measure': 'heart rate', 'timeFrame': 'six hours after recruitment'}, {'measure': 'stroke volume', 'timeFrame': 'six hours after recruitment'}, {'measure': 'urine output', 'timeFrame': 'six hours after recruitment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Disorder; Mental, Sedative', 'Pain, Postoperative', 'Surgery']}, 'descriptionModule': {'briefSummary': "This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of Propofol (infusion dosage range: 0.3 \\~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage range: 0.1 \\~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output and Hemodynamic Monitor at preset time points (time of recruitment \\[0h\\], 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid volume and drugs used were also recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-emergent major abdominal tumor surgery with ICU admission\n* the need of sedation during ICU stay\n\nExclusion Criteria:\n\n* age older than 99 years\n* age younger than 20 years\n* refractory arrhythmias\n* refractory shock status after resuscitation\n* new onset of myocardial infarction\n* severe heart failure or NYHA 4\n* APACHE score \\> 30 when recruiting\n* severe liver cirrhosis or CHILD B or C\n* organ transplantation within one year\n* pregnancy\n* allergic to propofol or dexmedetomidine'}, 'identificationModule': {'nctId': 'NCT02393066', 'briefTitle': 'Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'A Comparison of Hemodynamic Effects Between Dexmedetomidine and Propofol for Sedation in Patients With Major Abdominal Tumor Surgery', 'orgStudyIdInfo': {'id': '201407023MINA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'propofol', 'description': 'these patients are sedated with propofol infusion during ICU admission', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dexmedetomidine', 'description': 'these patients are sedated with dexmedetomidine infusion during ICU admission', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propofol-Lipuro'], 'description': 'Sedation', 'armGroupLabels': ['propofol']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'Sedation', 'armGroupLabels': ['dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital'}], 'overallOfficials': [{'name': 'Yu-Chang Yeh, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}