[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100322308":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":60,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":25,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"University Hospital Hradec Kralove","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group TCI","EXPERIMENTAL","induction and anesthesia will be held by using target-controll infusion",[13],"Procedure: Group TCI",{"label":15,"type":16,"description":17,"interventionNames":18},"Group TIVA","ACTIVE_COMPARATOR","induction and anesthesia will be held by manual dosing of propofol and sufentanil",[19],"Procedure: Group TIVA",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Induction and anesthesia will be done by using Gepth model for sufentanil and Schnider effect model for propofol. Anesthetics will be aplicated using infusion pump Agilia (Fresenius Kabi). Another titration will be according to target value of entropy between 40 and 60 and surgical pleth index below 35.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Induction of anesthesia will be done by titrating of propofol to the dose of 1.2 mg\u002Fkg and sufentanil 5-10 ug according to body weight, maintaining of anesthesia using continuous infusion of propofol 5 mg\u002F kg\u002Fhour and sufentanil 35 ug\u002Fhour to reach the target value of entropy between 40 and 60 and surgical pleth index below 35.",[15],[30],{"name":31,"affiliation":5,"role":32},"Pavel Dostal, MD, Ph.D.","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Vlasta Dostalova, MD. Ph.D.","CONTACT","+420777883571","vlasta.dostalova@fnhk.cz",[40],{"facility":5,"status":41,"city":42,"state":25,"zip":43,"country":44,"countryCode":25,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Hradec Králové","50005","Czechia",{"type":46,"coordinates":47},"Point",[48,49],15.83277,50.20923,{"lat":49,"lon":48},[52,56],{"name":53,"role":36,"phone":54,"phoneExt":25,"email":55},"Suchy Tomas, MD","00420495833218","suchy@fnhk.cz",{"name":57,"role":36,"phone":58,"phoneExt":25,"email":59},"Dostal Pavel, MD, PhD","00420495832828","pavel.dostal@fnhk.cz",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Dostalova Vlasta, MD, PhD","Principal Investigator","100322308","manual-versus-targer-controll-infusion-in-reduction-of-awareness-and-dreaming-100322308",false,"NCT03476213","Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming","Reduction of Awareness and Dreaming During Neurosurgical Procedures Using Target- Controlled Infusion, Comparison With Manual Total Intravenous Anesthesia TIVA.","Inclusion Criteria:\n\n* Glasgow Coma scale 15\n* ASA Physical Status Classification System I - III\n* planed surgery for brain tumor to 5 hours\n* postoperative awakening\n\nExclusion Criteria:\n\n* NYHA III, IV\n* abuse of stimulating drugs, grass, alcohol dependence\n* BMI over 40 in females and over 35 in men\n* propofol alergie\n* awake operations\n* postoperative arteficial ventilation","ALL","18 Years",{"count":74,"type":75},80,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study compares manual total intravenous anesthesia (TIVA) and target-controll infusion (TCI) in reduction of awareness and dreaming, and the haemodynamical stability during operation. Half of patients will be anesthetized using manual TIVA and other half using TCI.",[81],"Anesthesia Awareness",[81,83,84,85],"Dreaming in anesthesia","Total intravenous anesthesia","Target-controll infusion","2024-05-09",{"date":88,"type":89},"2024-05-10","ACTUAL",{"date":91,"type":89},"2018-03-16",{"date":93,"type":75},"2027-06-30",{"name":5,"class":6},1]