[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574614":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":31,"responsibleParty":49,"collaborators":10,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":65,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patiets, undergoing head and neck surgery or plastic surgery, with high risk of POD",null,"Each recruited patient, once on the operating bed, will be monitored with two BIS sensor, applied on the forehead in a non-invasive way, each for hemisphere.\n\nBIS Vista® monitor will be connected to our off-line laptop and software VitalDB will record: right\\&left BIS, BSR, Total Power, SEF, EMG, SQI and two BIS curves. Values of the study variables will be extract in these specific moments:(t1) BIS probe application (t2) 60\" before GA administration (t3) 60\" after myoresolution (t4) intubation (t5) surgical incision (t6) end of ipnosis (t7) 10 minutes after extubation.\n\nA daily follow-up for the first 5 post-operative days will verify the onset of POD and a telephone follow-up will be performed at 30 and 90 post-operative days to verify the onset of POD and POCD (CAM scale, 6-CIT scale and EQ50 for tracheostomized patients).",[13],"Device: Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Bilateral Bispetral Index Monitor will be applied on forehead of our patients, before surgery begins","In patients undergoing surgery and general anesthesia, the investigators want to examine -using bilateral BIS monitor- synthetic electroencephalographic differences between the two cerebral hemispheres (ASYM) to evaluate any correlation with the development of POD and POCD in the post-operative period.",[9],[21],"CAM and CIT scales for diagnosis of POD and POCD will be post operativelly administrated to our patients",[23],{"name":24,"affiliation":5,"role":25},"Maria Paola Lauretta, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":24,"role":28,"phone":29,"phoneExt":10,"email":30},"CONTACT","0512143444","mariapaola.lauretta@aosp.bo.it",[32],{"facility":5,"status":33,"city":34,"state":10,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Bologna","40138","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],11.33875,44.49381,{"lat":42,"lon":41},[45,48],{"name":46,"role":28,"phone":29,"phoneExt":10,"email":47},"Maria Paola Lauretta, MD, EDAIC","mariapaola.lauretta@aodp.bo.it",{"name":24,"role":25,"phone":10,"phoneExt":10,"email":10},{"type":50,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100574614","bilateral-bispectral-index-asymmetries-and-post-operative-delirium-100574614",false,"NCT06761573","Bilateral Bispectral Index, Asymmetries and Post-operative Delirium","Bilateral Bispectral Index and Asymmetries in High Risk Patients for Posteoperative Delirium: An Observational, Prospective, Exploratory Study","DELBIS","Inclusion Criteria:\n\n-Patients, undergoing head\\&neck surgery, who have at least 3 of the following criteria (to establish \"a priori\" increased risk of POD):\n\n* Age\\> 70;\n* Male sex; or ASA III;\n* Smoker;\n* High blood pressure;\n\nExclusion Criteria:\n\n* ASA IV, V or ASA IE, IIE, IIIE (patients with anesthetic risk ASA\\>III and those undergoing urgent-emergency surgery will be excluded from the study);\n* Past positive medical history for:\n\n  * Stroke;\n  * Dementia;\n  * Cerebral aneurysm;\n  * Intracranial mass;\n  * Head trauma;\n  * Epilepsy;\n  * Diabetes mellitus;\n  * Previous neurosurgical intervention;\n  * Psychiatric illnesses requiring chronic treatment;\n* Patients undergoing surgery in the previous two weeks;\n* Patients whose hospitalization duration is estimated to be less than five days;\n* Lack of understanding of the Italian language or English;\n* Age \\\u003C18 years.","ALL","18 Years","90 Years",{"count":63,"type":64},84,"ESTIMATED","90 Days","OBSERVATIONAL","The primary objective of the study is to describe the value of interhemispheric asymmetry (ASYM), during the different intra- and peri-operative phases, in those patients who develop or do not develop post-operative delirium (POD) during the first 30 post-operative days and postoperative cognitive disfunction (POCD) in the first 90 post-operative days, in a population undergoing head\\&neck and plastic surgery with a priori increased probability of POD.",[69,70],"Postoperative Delirium","Postoperative Cognitive Dysfunction",[72,73,74,69,70,75],"Bilateral Bispectral Index","Head&Neck Surgery","Plastic Surgery","Interhemispheric asymmetries","2024-12-30",{"date":78,"type":79},"2025-01-07","ACTUAL",{"date":81,"type":79},"2020-07-07",{"date":83,"type":64},"2026-12",{"name":5,"class":6},1]