[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601668":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":41,"centralContacts":49,"locations":55,"responsibleParty":69,"collaborators":53,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":53,"enrollmentInfo":81,"targetDuration":53,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":93,"overallStatus":57,"whyStopped":53,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Romanian Society for Enteral and Parenteral Nutrition","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Remimazolam with Traumatic Orthopedic Surgery","ACTIVE_COMPARATOR","Participants in this arm receive intravenous Remimazolam sedation during regional anesthesia for traumatic orthopedic surgery. Sedation dosing follows the protocol of 5 mg IV over 1 minute with supplemental doses as needed. Propofol infusion may be used as an adjunct.",[13],"Drug: REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]",{"label":15,"type":10,"description":16,"interventionNames":17},"Remimazolam with Non-Traumatic Orthopedic Surgery","Participants receive intravenous Remimazolam sedation during regional anesthesia for elective (non-traumatic) orthopedic surgery. Sedation dosing and adjunct propofol use are consistent with the protocol.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Midazolam with Traumatic Orthopedic Surgery","Participants receive intravenous Midazolam sedation during regional anesthesia for traumatic orthopedic surgery. Dosing is 0.025-0.05 mg\u002Fkg IV with supplemental doses if needed. Propofol may be used as adjunct sedation.",[22],"Drug: Midazolam",{"label":24,"type":10,"description":25,"interventionNames":26},"Midazolam with Non-Traumatic Orthopedic Surgery","Participants receive intravenous Midazolam sedation during regional anesthesia for elective (non-traumatic) orthopedic surgery. Sedation dosing and propofol adjunct use follow the study protocol.",[22],[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Midazolam","Midazolam:\n\nA commonly used benzodiazepine for sedation, administered intravenously at 0.025-0.05 mg\u002Fkg with supplemental doses as required. Known for effective anxiolysis and sedation but with a longer recovery profile compared to remimazolam.",[24,19],[34],"Dormicum, Versed, Midazolam Hydrochloride",{"type":29,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"REMIMAZOLAM BESYLATE 2.5 Mg in 1 mL INTRAVENOUS INJECTION, POWDER, LYOPHILIZED, for SOLUTION [BYFAVO]","Remimazolam:\n\nA novel, ultra-short-acting benzodiazepine used for procedural sedation. Administered intravenously at 5 mg over 1 minute with supplemental dosing as needed. Characterized by rapid onset and quick recovery, with minimal residual sedation.",[15,9],[40],"ByfaByfavo, Remimazolam Besylate, Remimazolam",[42,46],{"name":43,"affiliation":44,"role":45},"Liliana Mirea, Associate Professor, MD","Clinical Emergency Hospital of Bucharest","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":44,"role":48},"Ana Maria Dumitriu, MD, PhD","STUDY_DIRECTOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},"CONTACT","+40 721 277 447",null,"cotae_ana_maria@yahoo.com",[56],{"facility":44,"status":57,"city":58,"state":53,"zip":53,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Bucharest","Romania","RO",{"type":62,"coordinates":63},"Point",[64,65],26.10626,44.43225,{"lat":65,"lon":64},[68],{"name":47,"role":51,"phone":52,"phoneExt":53,"email":54},{"type":70,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100601668","phase-3-remimazolam-vs-midazolam-for-sedation-and-cognitive-outcomes-in-orthopedic-surgery-100601668",false,"NCT07113483","Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery","Randomized, Double-Blind, 2x2 Factorial Trial of Remimazolam vs. Midazolam on Sedation and Early Cognitive Outcomes in Patients Undergoing Traumatic or Non-Traumatic Orthopedic Surgery With Regional Anesthesia","REMIND-ORTHO","Inclusion Criteria:\n\n* Adults aged 65 years or older.\n* Scheduled for traumatic or non-traumatic orthopedic surgery under regional anesthesia.\n* Able to provide informed consent or have a legally authorized representative provide consent.\n\nExclusion Criteria:\n\n* Patient refusal to participate.\n* Mini-Cog score less than 3 (indicative of significant cognitive impairment).\n* Severe hepatic or renal failure.\n* Known allergy to benzodiazepines or propofol.\n* History of benzodiazepine dependence.","ALL","65 Years",{"count":82,"type":83},120,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","This study aims to compare two medications, Remimazolam and Midazolam, used for sedation during orthopedic surgeries performed under regional anesthesia. We want to find out which medication provides better sedation during the procedure and which one affects early recovery of brain function after surgery.\n\nOlder adults (65 years and above) undergoing surgery for bone injuries or conditions will participate. We will monitor their sedation levels, blood pressure, heart rate, side effects, and how quickly they recover after surgery. We also want to see if either medication causes fewer problems with thinking and memory shortly after surgery.\n\nThe study is designed so neither the patients nor the medical staff know which medication is being given, to ensure unbiased results. Participants will be randomly assigned to receive either Remimazolam or Midazolam.\n\nThe information gathered will help doctors choose the safest and most effective sedative for older patients undergoing orthopedic surgeries, potentially improving patient comfort and recovery.",[89,90,91,92],"Postoperative Cognitive Dysfunction","Orthopedic Procedures","Postoperative Pain Management","Hip Fracture",[94,30,95,96,97,98,99],"Remimazolam","Regional Anesthesia","Sedation","Cognitive dysfunction","Elderly patients","Trauma","2025-09-26",{"date":102,"type":103},"2025-10-01","ACTUAL",{"date":102,"type":83},{"date":106,"type":83},"2026-02-15",{"name":5,"class":6},1]