Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-29 @ 3:36 AM
Study NCT ID:
NCT04790734
Status:
COMPLETED
Last Update Posted:
2022-09-15
First Post:
2021-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-11-16', 'releaseDate': '2023-02-07'}], 'estimatedResultsFirstSubmitDate': '2023-02-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2021-03-09', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of time in the target sedation range without rescue sedation', 'timeFrame': 'From the beginning of using study sedatives until being extubated, being discharged from our ICU, the study drug was stopped for 24 hours by physicians, or 7 days after enrollment, whichever came first', 'description': 'The percentage of time in the target sedation range without rescue sedation'}], 'secondaryOutcomes': [{'measure': 'Length of ICU stay', 'timeFrame': 'From start of study to 28 days', 'description': 'Length of ICU stay'}, {'measure': '28-day mortality', 'timeFrame': 'From start of study to 28 days', 'description': '28-day mortality'}, {'measure': '7-day ventitlator free time', 'timeFrame': 'From start of study to 7 days', 'description': '7-day ventitlator free time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remimazolam besylate', 'Propofol', 'Intensive care unit', 'Mechanical ventilation'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of remimazolam compared to propofol for sedation in mechanically ventilated ICU patients.', 'detailedDescription': 'This is a single-center, prospective, randomized, controlled pilot study using remimazolam and propofol for sedation in mechanically ventilated ICU patients. Subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. Remifentanil is administered as the analgesic. Efficacy and safety profiles of remimazolam besylate are to be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 75 years;\n* Intubated and mechanically ventilated ≤96 hours before enrollment；\n* Expected to require continuous invasive ventilation and sedation ≥24 hours;\n* Requirement for light to moderate sedation (a RASS score of -3 to 0).\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\<18 or \\>30 kg/m2;\n* Acute severe neurological disorder and any other condition interfering with RASS assessment;\n* Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;\n* Heart rate less than 50 beats/min;\n* Second- or third-degree heart block in the absence of a pacemaker;\n* Unstable angina;\n* Acute myocardial infarction;\n* Left ventricular ejection fraction less than 30%;\n* Contraindicate or allergic to study drugs;\n* Moribund state;\n* Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);\n* Chronic kidney disease with glomerular filtration rate (GFR) \\< 60 ml/min/1.73m2;\n* Alcohol abuse;\n* Myasthenia gravis;\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT04790734', 'briefTitle': 'Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU Patients: a Pilot Study', 'orgStudyIdInfo': {'id': 'WUHICU202101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam', 'description': 'Patients in the remimazolam group received remimazolam besylate at an initial infusion rate of 0.15 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.', 'interventionNames': ['Drug: Sedation drugs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Patients in the propofol group received propofol at an initial infusion rate of 2.0 mg/kg/h and adjusted to maintain a RASS score of -3 to 0.', 'interventionNames': ['Drug: Sedation drugs']}], 'interventions': [{'name': 'Sedation drugs', 'type': 'DRUG', 'description': 'Different sedation drugs', 'armGroupLabels': ['Propofol', 'Remimazolam']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'country': 'China', 'facility': 'Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'You Shang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Xiaobo Yang, MD', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-02-07', 'type': 'RELEASE'}, {'date': '2023-11-16', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Xiaobo Yang, MD, MD, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}