[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632704":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":54,"studyPopulation":55,"armGroups":56,"interventions":50,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":88,"collaborators":50,"id":91,"slug":50,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":50,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":50,"enrollmentInfo":99,"targetDuration":50,"studyType":102,"phases":50,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":114,"whyStopped":50,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Ankara Ataturk Sanatorium Training and Research Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":50},[9],{"measure":10,"description":11,"timeFrame":12},"Intraoperative cerebral oxygenation","Intraoperative cerebral oxygenation in patients receiving desflurane-remifentanyl or propofol-remifentanyl anesthesia","During surgery",[14,18,22,25,29,33,36,39,43,46],{"measure":15,"description":16,"timeFrame":17},"Intraoperative SpO2 Values","Intraoperative SpO2 values will be recorded every 20 minutes","During Surgery (per 20 minutes)",{"measure":19,"description":20,"timeFrame":21},"Intraoperative Heart Rate Values","Intraoperative heart rate values will be recorded every 20 minutes","During surgery (Per 20 minutes)",{"measure":23,"description":24,"timeFrame":21},"Intraoperative TV-Tidal Volume Values","Intraoperative TV-Tidal Volume values will be recorded every 20 minutes",{"measure":26,"description":27,"timeFrame":28},"Anesthetic complications","Postoperative anesthetic complications","From end of surgery until hospital discharge",{"measure":30,"description":31,"timeFrame":32},"Correlation between systemic oxygenation and cerebral oxygenation","Correlation of intraoperative cerebral oxygenation with systemic oxygenation parameters","During surgery (per 20 minutes)",{"measure":34,"description":35,"timeFrame":17},"Intraoperative SpO2\u002FFiO2 Values","Intraoperative SpO2\u002FFiO2 values will be recorded every 20 minutes",{"measure":37,"description":38,"timeFrame":17},"Intraoperative Oxygen Saturation Index- OSI Values","The Oxygen Saturation Index- OSI values will be recorded every 20 minutes",{"measure":40,"description":41,"timeFrame":42},"Intraoperative Blood Pressure Values","Intraoperative blood pressure values will be recorded every 20 minutes","During Surgery ( Per 20 minutes)",{"measure":44,"description":45,"timeFrame":42},"Intraoperative PIP- Peak Inspiratory Pressure Values","Intraoperative PIP- Peak Inspiratory Pressure values will be recorded every 20 minutes",{"measure":47,"description":48,"timeFrame":49},"Intraoperative Pplat-Plateau Pressure Values","Intraoperative Pplat-Plateau Pressure values will be recorded every 20 minutes","During Surgery (Per 20 minutes)",null,{"allocation":50,"interventionModel":50,"interventionModelDescription":50,"primaryPurpose":50,"observationalModel":52,"timePerspective":53,"maskingInfo":50},"COHORT","PROSPECTIVE","This observational study aims to investigate the relationship between intraoperative cerebral oxygenation and systemic oxygenation parameters in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.\n\nCerebral oxygenation monitoring using near-infrared spectroscopy (NIRS) has become increasingly important in perioperative care, as it provides real-time, non-invasive information about cerebral perfusion and oxygen balance. However, the relationship between cerebral oxygenation and routinely monitored systemic oxygenation parameters remains unclear. This study is designed to evaluate these associations under standardized clinical conditions.\n\nAfter obtaining ethics committee approval, patients scheduled for elective laparoscopic cholecystectomy will be prospectively enrolled. All procedures will be conducted according to routine clinical practice without any additional intervention. Anesthesia management will be performed by experienced anesthesiologists following institutional protocols.\n\nPatients will be observed according to the anesthesia technique applied: desflurane-remifentanyl anesthesia or total intravenous anesthesia (TIVA) with propofol-remifentanyl. Intraoperative monitoring will include standard hemodynamic parameters, peripheral oxygen saturation (SpO₂), cerebral oxygenation (NIRS), bispectral index (BIS), respiratory mechanics, and derived indices such as the SpO₂\u002FFiO₂ ratio and oxygen saturation index (OSI).\n\nMeasurements will be recorded at predefined time points, including before and after induction, after intubation, after positioning, at 20-minute intervals during surgery, and after extubation. Additional intraoperative data such as anesthetic drug consumption, duration of surgery and anesthesia, blood loss, transfusion requirements, urine output, and recovery time will also be documented.\n\nPostoperative outcomes will include pain scores assessed by the Numeric Rating Scale (NRS) at multiple time points, intensive care unit (ICU) admission, and postoperative complications such as nausea, vomiting, hemodynamic instability, respiratory complications, and cognitive dysfunction. Cognitive and anxiety assessments will be performed using the Montreal Cognitive Assessment (MoCA) and Beck Anxiety Scale. Length of hospital stay, ICU stay, and mortality will also be recorded.\n\nThe findings of this study are expected to contribute to a better understanding of the relationship between cerebral and systemic oxygenation and may help optimize intraoperative monitoring strategies in routine anesthesia practice.","Adult patients undergoing elective surgery under general anesthesia, receiving either desflurane - remifentanyl or propofol- remifentanyl anesthesia",[57,60],{"label":58,"type":50,"description":59,"interventionNames":50},"Desflurane+Remifentanyl Group","Desflurane+Remifentanyl Group: Patients who receive remifentanil and desflurane during anesthesia",{"label":61,"type":50,"description":62,"interventionNames":50},"Propofol + Remifentanyl Group","Propofol + Remifentanyl Group: Patients who receive remifentanyl and propofol during anesthesia",[64],{"name":65,"affiliation":5,"role":66},"Hilal Sazak, Prof. Dr","PRINCIPAL_INVESTIGATOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":50,"email":72},"ELİF ECE REIS, MD","CONTACT","+90 552 716 15 28","eer_933@hotmail.com",[74],{"facility":75,"status":50,"city":76,"state":76,"zip":77,"country":78,"countryCode":50,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Ankara Atatürk Sanatorium Training and Research Hospital","Ankara","06010","Turkey (Türkiye)",{"type":80,"coordinates":81},"Point",[82,83],32.85427,39.91987,{"lat":83,"lon":82},[86],{"name":87,"role":70,"phone":71,"phoneExt":50,"email":72},"Elif Ece Reis, MD",{"type":66,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Hilal GUNAL SAZAK","Professor of Anesthesiology","100632704",false,"NCT07517146","Comparison of the Effects of Desflurane-Remifentanyl and Propofol-Remifentanyl Anesthesia on Intraoperative Cerebral Oxygenation in Patients Undergoing Laparoscopic Cholecystectomy","Comparison of the Effects of Desflurane-Remifentanyl and Propofol-Remifentanyl Anesthesia on Intraoperative Cerebral Oxygenation and Postoperative Complications in Patients Undergoing Laparoscopic Cholecystectomy","Inclusion Criteria:\n\n* Those with ASA 1-2-3\n* Those who have undergone laparoscopic cholecystectomy\n* Those with BMI between 18-40 kg\u002Fm2\n\nExclusion Criteria:\n\n* Emergency surgeries\n* Individuals with neurological disorders, diseases, or drug (opioid or sedative) use that affect cognitive function\n* Individuals who do not speak Turkish\n* Individuals who have received general anesthesia within the last 7 days\n* Individuals with severe organ dysfunction\n* Individuals allergic to the drugs used in the study","ALL","18 Years",{"count":100,"type":101},84,"ESTIMATED","OBSERVATIONAL","Study Population:\n\nPatients undergoing elective laparoscopic cholecystectomy under general anesthesia will be included.\n\nStudy Design:\n\nThis is an observational study. No interventions outside routine clinical practice will be applied. All procedures will be performed by experienced anesthesiologists according to standard institutional protocols.\n\nData Collection\n\nPreoperative Data:\n\nThe following variables will be recorded from anesthesia charts:\n\nDemographics: age, sex, height, weight, body mass index (BMI) Education level Smoking, alcohol, and substance use status Routine preoperative laboratory tests\n\nClinical scores:\n\nCharlson Comorbidity Index (CCI) Beck Anxiety Scale ARISCAT Score STOP-BANG Score Montreal Cognitive Assessment (MoCA) ASA Physical Status Classification\n\nIntraoperative Data:\n\nPatients will be observed in two groups based on anesthesia technique:\n\nDesflurane + remifentanyl Total intravenous anesthesia (TIVA: propofol + remifentanyl)\n\nThe following parameters will be recorded:\n\nHemodynamic data: blood pressure, heart rate Oxygenation parameters: SpO₂, SpO₂\u002FFiO₂ ratio Cerebral and depth monitoring: NIRS, BIS Respiratory mechanics Oxygen Saturation Index (OSI = \\[Pmean × FiO₂\\] \u002F SpO₂) Mechanical ventilator parameters\n\nTime Points for Measurement:\n\nBefore induction After induction After intubation Every 20 minutes intraoperatively After extubation\n\nAdditional Intraoperative Variables:\n\nDuration of surgery and anesthesia\n\nTotal anesthetic drug consumption:\n\nDesflurane and remifentanyl Propofol and remifentanyl (TIVA group) Intraoperative blood transfusion (yes\u002Fno) Total blood loss Urine output Recovery time Postoperative Follow-up ICU admission (planned or unplanned)\n\nPain assessment using Numeric Rating Scale (NRS):\n\nPACU Postoperative 1st, 3rd, 6th, 12th, and 24th hours\n\nPostoperative Complications:\n\nNausea and vomiting Hypotension Arrhythmia (bradycardia, tachycardia) Pulmonary edema Atelectasis Pneumonia Pneumothorax Pleural effusion Cognitive dysfunction\n\nOther Outcomes:\n\nPostoperative MoCA and Beck Anxiety Scale scores Length of hospital stay Length of ICU stay (if applicable) Mortality during follow-up",[105,106],"ıntraoperative Cerebral Oxygenation","Cerebral Oxygenation Monitoring",[108,109,110,111,112,113],"NIRS","BIS Monitoring","Laparoscopic Cholecystectomy","desflurane","remifentanil","propofol","NOT_YET_RECRUITING","2026-04-01",{"date":117,"type":118},"2026-04-08","ACTUAL",{"date":120,"type":101},"2026-04-06",{"date":122,"type":101},"2026-09",{"name":5,"class":6},1]