[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628865":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":25,"responsibleParty":41,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":10,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Sakarya University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients Undergoing Laparoscopic Hysterectomy in Trendelenburg Position",null,"This cohort includes adult female patients undergoing elective laparoscopic hysterectomy under general anesthesia. All participants receive standard intraoperative monitoring as part of routine clinical care. In addition to routine monitoring, depth of anesthesia is assessed using the Patient State Index (PSI), and frontal cerebral oxygen saturation (rSO₂) is measured using near-infrared spectroscopy sensors.\n\nPhysiological parameters including PSI, cerebral oxygen saturation, mean arterial pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide are recorded at predefined intraoperative time points before and after pneumoperitoneum and Trendelenburg positioning.\n\nNo intervention is performed for research purposes. Surgical positioning and anesthetic management follow routine clinical practice, and the study involves only the observational recording of physiological parameters.",[13],{"name":14,"affiliation":15,"role":16},"Ayca Tas Tuna, Professor, M.D.","Sakarya University Faculty of Medicine","PRINCIPAL_INVESTIGATOR",[18,22],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","+90 532 300 48 26","aycatas@yahoo.com",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":10},"Ahmet R Dogan, M.D.","+905427988070",[26],{"facility":27,"status":28,"city":29,"state":10,"zip":10,"country":30,"countryCode":10,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation","RECRUITING","Sakarya","Turkey (Türkiye)",{"type":32,"coordinates":33},"Point",[34,35],32.07583,39.50333,{"lat":35,"lon":34},[38],{"name":39,"role":19,"phone":10,"phoneExt":10,"email":40},"Ahmet Ridvan Dogan","a.ridvandogan@gmail.com",{"type":16,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ayça Taş Tuna","Prof.Dr.","100628865","effect-of-trendelenburg-position-on-patient-state-index-100628865",false,"NCT07467200","Effect of Trendelenburg Position on Patient State Index","Effect of the Trendelenburg Position on Patient State Index and Frontal Cerebral Oxygenation: A Prospective Observational Study","Inclusion Criteria:\n\n* Female patients aged 18-65 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Scheduled for elective laparoscopic hysterectomy under general anesthesia\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* History of neurological disease (e.g., stroke, epilepsy)\n* Known cerebrovascular disease, glaucoma, or retinal disease\n* Severe cardiac or pulmonary disease\n* Contraindication to near-infrared spectroscopy sensor placement\n* Obesity (Body Mass Index \\> 35 kg\u002Fm²)","FEMALE","18 Years","65 Years",{"count":55,"type":56},60,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate whether the Trendelenburg position affects electroencephalography-based depth of anesthesia monitoring and cerebral oxygenation during general anesthesia.\n\nThe main questions it aims to answer are:\n\n* Does the Trendelenburg position cause a change in the Patient State Index (PSI), an Electroensephalography (EEG)-derived indicator of anesthetic depth?\n* Are changes in PSI associated with changes in frontal cerebral oxygen saturation (rSO₂) and hemodynamic parameters?\n\nThe study will include adult female patients undergoing elective laparoscopic gynecologic surgery under general anesthesia.\n\nParticipants will receive standard anesthesia and routine intraoperative monitoring. In addition to standard monitoring, Patient State Index (PSI) and frontal cerebral oxygen saturation (rSO₂) will be recorded using non-invasive sensors. No additional intervention will be performed for research purposes.\n\nPhysiological parameters including PSI, cerebral oxygen saturation, mean arterial pressure, heart rate, oxygen saturation, and end-tidal carbon dioxide will be recorded at predefined intraoperative time points before and after the Trendelenburg position.\n\nThe study aims to determine whether position-related physiological changes influence EEG-based anesthesia depth indices and to improve the interpretation of intraoperative brain monitoring.",[60],"Laparoscopic Hysterectomy",[62,63,64,65,66,67,68,69],"Trendelenburg Position","Patient State Index","Processed EEG","Depth of Anesthesia Monitoring","Cerebral Oxygenation","Near-Infrared Spectroscopy","General Anesthesia","Intraoperative Monitoring","2026-06-02",{"date":72,"type":73},"2026-06-04","ACTUAL",{"date":75,"type":73},"2026-05-01",{"date":77,"type":56},"2026-12-01",{"name":5,"class":6},1]