[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500012":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":30,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Patients older than 65 years of age will receive an intravenous infusion of Propofol with prespecified plasma targets. During its administration, registration of BIS values, frontal electroencephalography, and clinical signs of consciousness will be performed. Two models will be created and compared retrospectively: BIS (Eleveld Validation) and EEG Frontal Marker (New model).",[13],"Drug: Propofol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Propofol","Patients older than 65 years of age will receive an intravenous infusion of Propofol with prespecified plasma targets. During its administration, registration of BIS values, frontal electroencephalography, and clinical signs of consciousness will be performed.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Juan C. Pedemonte, MD","CONTACT","+ 56 22 3543270","jcpedemo@gmail.com",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":29},"Luis I. Cortinez, MD","icortinez@gmail.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Pontificia Universidad Católica de Chile","RECRUITING","Santiago","Santiago Metropolitan","8330024","Chile","CL",{"type":40,"coordinates":41},"Point",[42,43],-70.64827,-33.45694,{"lat":43,"lon":42},[46],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100500012","development-of-a-pharmacodynamic-model-for-propofol-in-older-adults-100500012",false,"NCT05790720","Development of a Pharmacodynamic Model for Propofol in Older Adults","Development of a Pharmacodynamic Model for Propofol in Older Adults (Development phaRmacodynamic mOdel Propofol oLdEr adulTs: DROPLET)","DROPLET","Inclusion Criteria:\n\n* Patients undergoing non-cardiac elective surgery requiring general anesthesia\n* American Society of Anesthesiologists Physical Status I to III\n\nExclusion Criteria:\n\n* Patients undergoing emergency surgery\n* Neurosurgical patients\n* History of alcohol abuse or recreational drug use\n* Known allergie to Propofol\n* Body mass index ≥ 35 Kg m-2\n* Unstable heart failure","ALL","65 Years","99 Years",{"count":61,"type":62},36,"ESTIMATED","INTERVENTIONAL",[65],"NA","The goal of this pharmacodynamic study is to develop a model for Propofol administration for older adults (\\>65 years). The main objective is to create a model based on a new pharmacodynamic parameter, derived from frontal electroencephalogram (EEG), to admininster Propofol in older adults. With this new model, the investigators aim to:\n\n* Evaluate the relationship between the plasmatic concentration, described by the Eleveld pharmacokinetic model, versus the effect of the drug represented with a new parameter derived from the intraoperative frontal EEG.\n* To validate the predictive ability of Eleveld's pharmacokinetic-pharmacodynamic model, based on the bispectral index (BIS), compared to the new model based on a parameter derived from intraoperative frontal EEG.\n\nParticipants will be asked to answer preoperative questionnaires, receive a Propofol intravenous infusion concomitantly with continuous BIS and EEG monitoring, and to be evaluated for clinical sings of loss and return of consciousness.",[68],"Aged",[17,70,71],"TCI","TIVA","2026-06-23",{"date":74,"type":75},"2026-06-26","ACTUAL",{"date":77,"type":75},"2024-06-01",{"date":79,"type":62},"2026-08-01",{"name":5,"class":6},1]