Nctid:
NCT06222294
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000015742", "term"=>"Propofol"}], "ancestors"=>[{"id"=>"D000006993", "term"=>"Hypnotics and Sedatives"}, {"id"=>"D000002492", "term"=>"Central Nervous System Depressants"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018686", "term"=>"Anesthetics, Intravenous"}, {"id"=>"D000018681", "term"=>"Anesthetics, General"}, {"id"=>"D000000777", "term"=>"Anesthetics"}], "browseLeaves"=>[{"id"=>"M18307", "name"=>"Propofol", "asFound"=>"COVID-19", "relevance"=>"HIGH"}, {"id"=>"M10043", "name"=>"Hypnotics and Sedatives", "relevance"=>"LOW"}, {"id"=>"M4107", "name"=>"Anesthetics", "relevance"=>"LOW"}, {"id"=>"M20766", "name"=>"Anesthetics, Intravenous", "relevance"=>"LOW"}, {"id"=>"M20761", "name"=>"Anesthetics, General", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "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"=>"2024-08-24", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-08-29", "studyFirstSubmitDate"=>"2023-12-28", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-03", "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"}}}}