[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650171":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":10,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":81,"whyStopped":10,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Marmara University Pendik Training and Research Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group TIVA",null,"Patients receiving sedation via conventional manually administered total intravenous anesthesia (TIVA). Propofol 1% is administered by the anesthesiologist via manual boluses as needed, guided by BIS values, hemodynamic variables, and clinical assessment.",[13],"Device: non invasive ETCO2 monitoring",{"label":15,"type":10,"description":16,"interventionNames":17},"group TCI","Patients receiving sedation via target-controlled infusion (TCI) using the Schnider pharmacokinetic model. Propofol 1% is administered via TCI device with patient-specific parameters (height, weight, age, sex) entered. Plasma target concentration is titrated between 0.5-3 µg\u002FmL. Sedation depth is adjusted according to BIS values and hemodynamic responses",[18,13],"Procedure: Target controlled infusion of propofol",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"PROCEDURE","Target controlled infusion of propofol","In patients in group TCI, target-controlled propofol sedation will be administered using an elevated (opioid) model, and the target concentration will be titrated between 1-2 mcg\u002Fml.",[15],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DEVICE","non invasive ETCO2 monitoring","The Capnostream® device records four variables (SpO₂, respiratory rate, non-invasive EtCO₂, and heart rate) every 30 seconds via a nasal cannula and integrates them into a single unitless value called the Integrated Pulmonary Index (IPI), ranging from 1 to 10. An IPI of 4 or below requires intervention, while 8-10 represents the normal range",[9,15],[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"dilara göçmen, asst prof","CONTACT","+90 5413439438","dilara.gocmen@marmara.edu.tr",[37],{"facility":38,"status":10,"city":39,"state":40,"zip":41,"country":42,"countryCode":10,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Seniyye Ülgen Zengin","Istanbul","Maltepe","34854","Turkey (Türkiye)",{"type":44,"coordinates":45},"Point",[46,47],28.94966,41.01384,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":52,"phoneExt":10,"email":53},"seniyye ülgen zengin, assoc prof","+90 216 606 11 41","suzengin@marmara.edu.tr",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100650171","tci-versus-manual-tiva-for-sedation-during-prone-kyphoplasty-effects-on-respiration-recovery-and-eeg-100650171",false,"NCT07745348","TCI Versus Manual TIVA for Sedation During Prone Kyphoplasty: Effects on Respiration, Recovery, and EEG","Investigation of the Effects of Target-Controlled Infusion (TCI) Anesthesia on Respiration, Recovery, and Electroencephalogram in Patients Undergoing Kyphoplasty in the Prone Position","Inclusion Criteria:\n\n\\- Age 18 years and older\n\n* ASA physical status classification I-III\n* Scheduled for kyphoplasty under sedation in the prone position\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Known allergy to any of the study medications\n\n  * ASA physical status classification IV or higher\n  * Patients deemed unsuitable for sedation (high pulmonary risk, morbid obesity, diagnosed severe obstructive sleep apnea)\n  * Refusal to participate or withdrawal of consent\n  * Diagnosis of dementia or Alzheimer's disease\n  * Communication difficulties precluding adequate assessment",true,"ALL","18 Years",{"count":67,"type":68},50,"ESTIMATED","OBSERVATIONAL","This single-center, prospective, observational study compares target-controlled infusion (TCI) versus manually administered total intravenous anesthesia (TIVA) for sedation in patients undergoing kyphoplasty in the prone position. The primary endpoints are the incidence of hypoxic episodes (SpO₂ \\\u003C 90%) and apneic attacks. Secondary endpoints include anesthesia quality scores, integrated pulmonary index (IPI) values, total propofol consumption, time to eye opening, time to full orientation, Modified Aldrete Scores and Richmond Agitation-Sedation Scale (RASS) scores in the recovery unit, and patient and surgeon satisfaction.",[72,73,74,75],"Kyphoplasty","Prone Position","Target Controlled Infusion of Propofol","End Tidal Carbon Dioxide",[77,78,79,80],"target controlled infusion","kyphoplasty","sedation","non-invasive etco2","NOT_YET_RECRUITING","2026-08-03",{"date":84,"type":85},"2026-08-04","ACTUAL",{"date":87,"type":68},"2026-07-10",{"date":89,"type":68},"2027-08-10",{"name":5,"class":6},1]