[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497024":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":61,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":25,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":25,"enrollmentInfo":72,"targetDuration":25,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"MemorialCare Health System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Analgesia First Sedation","EXPERIMENTAL","Subjects will be randomized to receive analgesia-first sedation by intermittent doses of Fentanyl (25 mcg), instead of continuous IV infusions. If the intermittent IVP x4 fails to achieve the target pain score, an infusion starts at 50 mcg\u002Fhr and titration by 25 mcg q15 minutes. If sedation score is not achieved, propofol infusion starts at 5 mcg\u002Fkg\u002Fmin to achieve goal RASS of 0 to -2. Subjects will be assessed for a ventilator weaning trial daily.",[13],"Other: Analgesia First Sedation Strategy for Mechanically Ventilated (MV) Trauma Subjects",{"label":15,"type":16,"description":17,"interventionNames":18},"Protocol Directed Sedation and Daily Sedation Interruption","ACTIVE_COMPARATOR","Pain management will be initiated with intravenous fentanyl at 50 mcg\u002Fhr. If the goal pain score is not achieved, use bolus doses and increase the rate by 25 mcg\u002Fhr every 15 minutes until the goal pain score is achieved. If the goal pain score is surpassed, lower the rate by 25 mcg\u002Fhr every 15 minutes. If at goal pain score, continue the current dose. If RASS scores less than the goal and Propofol is already off - decrease Fentanyl infusion.\n\nAgitation management will be initiated with intravenous propofol starting at 5 mcg\u002Fkg\u002Fmin. Bolus doses will be used, and the rate will be increased by 5 mcg\u002Fkg\u002Fmin every 15 minutes until goal RASS is achieved. If goal RASS is surpassed, lower the rate by 5 mcg\u002Fkg\u002Fmin every 15 minutes until goal RASS is achieved. Bolus dose: 25 mg IVP every 5 minutes up to 2 doses PRN agitation before increasing infusion rate. Midazolam or dexmedetomidine substitutions for propofol are allowed according to the institutional protocol.",[19],"Other: Protocol Directed Sedation and Daily Sedation Interruption",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Analgesia First Sedation Strategy for Mechanically Ventilated (MV) Trauma Subjects","The Intervention is using a sedation strategy for MV trauma that initially targets pain by intermittent boluses followed by an IV drip only if required. Sedatives are limited to agitation management and for a limited duration as needed. This \"analgo-sedation\" approach differs from the approach of using IV drips of analgesics and sedatives simultaneously and discontinuing both once daily to assess subjects.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"The active comparator in this study is using a sedation strategy for MV trauma that uses IV drips of analgesics and sedatives simultaneously and discontinues both once daily to assess subjects.",[15],[30],{"name":31,"affiliation":32,"role":33},"Maged Tanios, MD, MPH","Long Beach Memorial Medical Center","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","562-424-800","tanios@memorialcare.org",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Hyunsoon Park, RN","562-933-7176","hpark@memorialcare.org",[44],{"facility":32,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Long Beach","California","90806","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-118.18923,33.76696,{"lat":55,"lon":54},[58,59],{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"name":60,"role":33,"phone":25,"phoneExt":25,"email":25},"Maged Tanios, MD. MPH",{"type":33,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Maged Tanios, MD","Medical Director","100497024","analgesia-first-sedation-in-trauma-patients-100497024",false,"NCT05751863","Analgesia-First Sedation in Trauma Patients","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. Mechanically ventilated with an expected duration of MV ≥ 48h\n3. Initiated continuous sedative\u002Fanalgesic infusions by the ICU team\n4. Patient is a candidate for MV weaning\n\nExclusion Criteria:\n\n1. Admission after resuscitation from cardiac arrest\n2. Significant neurological deficit due to a chronic disorder\n3. History of alcohol dependence and\u002For other illicit drug abuse\n4. Prior administration of continuous sedative\u002Fanalgesic from a transferring institution\n5. Patient receiving neuromuscular blocking agents\n6. Allergy to midazolam, lorazepam, and\u002For propofol","ALL","18 Years",{"count":73,"type":74},170,"ESTIMATED","INTERVENTIONAL",[77],"NA","The study's aim is to ascertain the best approach for providing sedation and pain management for patients who have sustained trauma and are requiring respiratory support from a mechanical ventilator. The common approach to patients who need mechanical ventilation is to provide continuous drips of sedatives and pain medicine and awaken the patient once a day to check the brain functions. Another approach is to provide pain medicine and reserve sedatives for only a short duration when needed. The difference between approaches has not been studied in Trauma patients.",[80,81],"Mechanical Ventilation","Respiratory Failure",[83,84,85,86],"Trauma","Analgesia","Sedation","Intubation","2025-07-03",{"date":89,"type":90},"2025-07-09","ACTUAL",{"date":92,"type":90},"2023-04-01",{"date":94,"type":74},"2026-09-01",{"name":5,"class":6},1]