Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT01937767
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2013-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remimazolam Phase II Cardiac Anesthesia Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D000074584', 'term': 'WW Domain-Containing Oxidoreductase'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000077123', 'term': 'Rocuronium'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D007267', 'term': 'Injections'}], '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': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000074583', 'term': 'Short Chain Dehydrogenase-Reductases'}, {'id': 'D064430', 'term': 'NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases'}, {'id': 'D000429', 'term': 'Alcohol Oxidoreductases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D025521', 'term': 'Tumor Suppressor Proteins'}, {'id': 'D009363', 'term': 'Neoplasm Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2014-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-15', 'studyFirstSubmitDate': '2013-08-29', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with successful anesthesia', 'timeFrame': 'Between the start of study medication and the end of the surgical procedure (up to approx 12 hours)', 'description': 'Successful anesthesia was defined as no use of rescue sedative medication between start of the study medication and end of the surgical procedure completion of last skin suture.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['General Anesthesia']}, 'descriptionModule': {'briefSummary': 'This phase II study in patients undergoing elective cardiac surgery will evaluate the efficacy, safety, and pharmacokinetics of remimazolam, compared with propofol and sevoflurane, during the induction and maintenance of general anesthesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for major elective cardiac surgery.\n* scheduled for mechanical ventilation via tracheal intubation.\n\nExclusion Criteria:\n\n* thoraco-abdominal replacement of the aorta or other procedure expected to be accompanied by a massive hemorrhage (at least 15% of the circulating blood volume).'}, 'identificationModule': {'nctId': 'NCT01937767', 'briefTitle': 'Remimazolam Phase II Cardiac Anesthesia Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Paion UK Ltd.'}, 'officialTitle': 'A Randomized, Single-blind Phase II Study Evaluating the Efficacy, Safety and Pharmacokinetics of Remimazolam in General Anesthesia in Adult Patients Undergoing Cardiac Surgery, Including Follow-up Sedation in the PACU/ICU', 'orgStudyIdInfo': {'id': 'CNS7056-010'}, 'secondaryIdInfos': [{'id': '2013-001113-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Propofol', 'description': 'Induction: Propofol, fentanyl, rocuronium. Maintenance: Sevoflurane, remifentanil.', 'interventionNames': ['Drug: Propofol', 'Drug: Sevoflurane', 'Drug: Remifentanil', 'Drug: Fentanyl', 'Drug: Rocuronium']}, {'type': 'EXPERIMENTAL', 'label': 'Remimazolam 6 mg/kg/hr', 'description': 'Induction: Remimazolam 6 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.', 'interventionNames': ['Drug: Remimazolam', 'Drug: Remifentanil', 'Drug: Fentanyl', 'Drug: Rocuronium']}, {'type': 'EXPERIMENTAL', 'label': 'Remimazolam 12 mg/kg/hr', 'description': 'Induction: Remimazolam 12 mg/kg/hr, fentanyl, rocuronium. Maintenance: Remimazolam up to 2 mg/kg/hr titrated to effect, remifentanil.', 'interventionNames': ['Drug: Remimazolam', 'Drug: Remifentanil', 'Drug: Fentanyl', 'Drug: Rocuronium']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'otherNames': ['ByFavo, Aptimyda, CNS7056'], 'armGroupLabels': ['Remimazolam 12 mg/kg/hr', 'Remimazolam 6 mg/kg/hr']}, {'name': 'Propofol', 'type': 'DRUG', 'otherNames': ['Propofol-®Lipuro 10 mg/ml'], 'armGroupLabels': ['Propofol']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevofluran Baxter'], 'armGroupLabels': ['Propofol']}, {'name': 'Remifentanil', 'type': 'DRUG', 'otherNames': ['Ultiva (remifentanil hydrochloride) for Injection'], 'armGroupLabels': ['Propofol', 'Remimazolam 12 mg/kg/hr', 'Remimazolam 6 mg/kg/hr']}, {'name': 'Fentanyl', 'type': 'DRUG', 'otherNames': ['Fentanyl-Janssen'], 'armGroupLabels': ['Propofol', 'Remimazolam 12 mg/kg/hr', 'Remimazolam 6 mg/kg/hr']}, {'name': 'Rocuronium', 'type': 'DRUG', 'otherNames': ['Esmeron 10mg/ml solution for injection'], 'armGroupLabels': ['Propofol', 'Remimazolam 12 mg/kg/hr', 'Remimazolam 6 mg/kg/hr']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Herzzentrum Leipzig GmbH', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Stefan Probst, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center Leipzig - University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paion UK Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aptiv Solutions', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}