Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-01-01 @ 7:56 PM
Study NCT ID:
NCT05015361
Status:
COMPLETED
Last Update Posted:
2021-08-20
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Remimazolam Tosilate compared with Propofol Injection'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-15', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-15', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The time to maintain target sedation as a percentage of the total study administration time.', 'timeFrame': 'through study completion,an average of about 1 hour'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects who achieved target sedation within 3 minutes after starting intravenous injection of load dose test drugs;', 'timeFrame': '3 minutes after administration'}, {'measure': 'Proportion of subjects receiving remedial sedation;', 'timeFrame': 'through study completion,an average of about 1 hour'}, {'measure': 'The time from the start of intravenous injection of load dose test drug to the first achievement of target sedation;', 'timeFrame': 'Time to achieve target sedation, an average of about 4 minutes'}, {'measure': 'The time from stopping infusion of test drugs to reaching MOAA/S level 5 for the first time after operation', 'timeFrame': 'Recovery time, an average of about 7 minutes'}, {'measure': "Anesthesiologists' satisfaction with sedation", 'timeFrame': 'through study completion,an average of about 1 hour'}, {'measure': "Evaluation of subjects' satisfaction with sedation treatment;", 'timeFrame': 'through study completion,an average of about 1 hour'}, {'measure': 'Incidence of anterograde amnesia.', 'timeFrame': 'through study completion,an average of about 1 hour'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Local Anesthesia Assisted Sedation']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to provide a written informed consent\n2. Subjects requiring local anesthesia assisted sedation\n3. Male or female\n4. Meet the weight standard\n5. Conform to the ASA Physical Status Classification\n\nExclusion Criteria:\n\n1. Previous respiratory or pulmonary diseases\n2. Subjects who had received general anesthesia\n3. Subjects with a history of myocardial infarction or unstable angina pectoris\n4. Subjects with atrioventricular block or cardiac insufficiency\n5. Subjects with a history of ischemic stroke or transient ischemic attack\n6. Subjects with poor blood pressure control after medication\n7. Subjects with abnormal clotting function\n8. Subjects with a history of mental illness and a history of cognitive impairment epilepsy\n9. Subjects with a history or possibility of a difficult airway\n10. Subject with a history of substance abuse and drug abuse\n11. Abnormal values in the laboratory\n12. Allergic to a drug ingredient or component\n13. Pregnant or nursing women\n14. No birth control during the specified period of time\n15. Participated in clinical trials of other drugs (received experimental drugs)\n16. The inestigators determined that other conditions were inappropriate for participation in this clinical trial'}, 'identificationModule': {'nctId': 'NCT05015361', 'briefTitle': 'A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation -- a Multicenter, Randomized, Single Blind, Positive Drug Parallel Controlled Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'HR7056-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A/B', 'description': 'Treatment group A: Remimazolam Tosilate Treatment group B: Remimazolam Tosilate', 'interventionNames': ['Drug: Remimazolam Tosilate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment group C', 'description': 'Treatment group C: Propofol Injection.', 'interventionNames': ['Drug: Propofol Injection.']}], 'interventions': [{'name': 'Remimazolam Tosilate', 'type': 'DRUG', 'description': 'Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose', 'armGroupLabels': ['Treatment group A/B']}, {'name': 'Propofol Injection.', 'type': 'DRUG', 'description': 'Treatment group C: Propofol Injection.', 'armGroupLabels': ['Treatment group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}