Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT06222294
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2023-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Remimazolam Tosilate for Sedation in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2023-12-28', 'studyFirstSubmitQcDate': '2024-01-15', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of sedation success, sedation success is defined as the percentage of time maintaining target sedation in the entire drug administering time ≥ 70% without rescue sedation.', 'timeFrame': 'within 24 hours after administration of research drug'}], 'secondaryOutcomes': [{'measure': 'Percentage of time maintaining target sedation in the entire drug administering time.', 'timeFrame': 'within 24 hours after administration of research drug'}, {'measure': 'Percentage of subjects receiving rescue sedation', 'timeFrame': 'within 24 hours after administration of research drug'}, {'measure': 'The number of additional doses of the research drug', 'timeFrame': 'within 24 hours after administration of research drug]'}, {'measure': 'The total dosage of Fentanyl', 'timeFrame': 'within 24 hours after administration of research drug'}, {'measure': 'Wake-up time.', 'timeFrame': 'within 6 hours after stopping the research drug'}, {'measure': 'Stopping the research drug to extubation time.', 'timeFrame': 'within 6 hours after stopping the research drug'}, {'measure': 'Nursing scale score', 'timeFrame': 'follow-up period (approx. 5-10 minutes)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sedation in the ICU']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Remimazolam Tosilate for Injection for sedation in the ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients or their guardians are able to provide a written informed consent；\n2. Subjects have been treated with endotracheal intubation and mechanical ventilation, and is expected to receive sedation after randomization. The target level and duration of sedation meet the criteria；\n3. 18 Years to 80 Years Old, male or female；\n4. 18 kg/m2≤BMI≤30kg/m2；\n\nExclusion Criteria:\n\n1. Deep sedation is required, or continuous sedation is not needed during the study process；\n2. Participants (other than in endotracheal intubation) who are expected to require neuro-muscle blockers during sedation；\n3. History of epilepsy or status epilepticus;\n4. Myasthenia gravis or a history of myasthenia gravis;\n5. Severe arrhythmias or heart disease; the circulatory system is unstable;\n6. Subjects with a history of severe cardiovascular disease, or cerebrovascular disease, or neurological disease, or mental illness；\n7. Subjects with a history of drug abuse;\n8. Organ failure before randomization;\n9. Abnormal values of the laboratory examination;\n10. Allergic to relevant drugs ingredient or component;\n11. Pregnant or nursing women;\n12. Subjects who has participated in clinical trials of other interventions recently;\n13. Other conditions deemed unsuitable to be included.'}, 'identificationModule': {'nctId': 'NCT06222294', 'briefTitle': 'A Study of Remimazolam Tosilate for Sedation in the ICU', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Remimazolam Tosilate for Injection for Sedation in the Intensive Care Unit (ICU)', 'orgStudyIdInfo': {'id': 'HR7056-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam Tosilate for Injection', 'interventionNames': ['Drug: Remimazolam Tosilate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol Medium and Long Chain Fat Emulsion Injection', 'interventionNames': ['Drug: Propofol Medium and Long Chain Fat Emulsion Injection']}], 'interventions': [{'name': 'Remimazolam Tosilate', 'type': 'DRUG', 'description': 'Loading dose: 0.08mg/kg Maintenance dose: IV remimazolam tosilate, dose range 0-2.0mg/kg/h, increment or decrement of 0.1-0.2mg/kg/h', 'armGroupLabels': ['Remimazolam Tosilate for Injection']}, {'name': 'Propofol Medium and Long Chain Fat Emulsion Injection', 'type': 'DRUG', 'description': 'Loading dose: 0.3-0.5mg/kg Maintenance dose: IV Propofol Medium and Long Chain Fat Emulsion Injection, dose range 0.3-4.0mg/kg/h, increment or decrement of 0.3-0.6mg/kg/h', 'armGroupLabels': ['Propofol Medium and Long Chain Fat Emulsion Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}