[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581017":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":23,"studyPopulation":24,"armGroups":20,"interventions":20,"overallOfficials":20,"centralContacts":25,"locations":36,"responsibleParty":58,"collaborators":20,"id":60,"slug":20,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":20,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"General Anaesthesia effect on Awakening","Correlation between intraoperative dosage of Propofol and Remifentanil with respect to dichotomous outcome related to quality of awakening post GA.","2 years",[14,17],{"measure":15,"description":16,"timeFrame":12},"RASS Scale score","RASS (Richmond Assesmenet sedation scale) scale score at post-GA awakening Analysis of the association between perioperative indicators - age, BMI, Milan Complexity Score, APAIS - and outcome on awakening. The minimum RASS scale is - 5 (unresponsive patient after painfull stimulation) and the maximum is + 4 (comactive patient). The optimal RASS scale is 0\u002F-1.",{"measure":18,"description":19,"timeFrame":12},"NRS scale score","NRS (Numerical rating scale ) scale score at post-GA awakening Analysis of the association between perioperative indicators - age, BMI, Milan Complexity Score, APAIS - and outcome on awakening. The minimum NRS scale is 0 (no pain at all) and the maximum is 10 (the maximum pain ever suffered)",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":6,"timePerspective":22,"maskingInfo":20},"PROSPECTIVE","The project will have a total duration of 24 months and will mainly consist of a data collection phase (months 1-24) and a data analysis and results publication phase (months 15-24). Preoperative clinical and socio-demographic data will be collected from patients' medical records. Psychological variables will be administered to the patient before elective neurosurgical surgery.\n\nBIS-guided general anesthesia will be induced by administering sedative and analgesic drugs to the effector site Ce (Effect Site) by target-controlled infusion (TCI). Propofol and remifentanil will be titrated to maintain blood pressure, body temperature, pCO2 and SaO2 in a normal range and BIS values between 40 and 60. Pharmacological data will be relevant at the end of the intervention from the drug infusion pumps. The Recovery Room multidisciplinary team will assess the quality of awakening following the Awakening Chart (Figure 1). This assessment involves dichotomous scoring (yes\u002Fno; correct\u002Fincorrect) of specific items. To assess the recovery of consciousness, during the pre-extubation phase, simple requests\u002Fquestions will be asked of the patient: show tongue; show two fingers; give phone number; state place; identify what day is today; report date of birth; notify residence; perform simple multiplication (e.g., 4x5). The following variables will be collected during the periestubation phase: cough, blood pressure ± 20% of baseline, chills, NRS \\> 3, RASS \\\u003C -1 or \\> 0. An abbreviated version of the STAI questionnaire will also be administered to the patient to assess anxiety on awakening. Awakening is considered good and optimal only if a score of 13 is achieved.","Patients undergoing neurosurgical surgery afferent to the Department of Neurosurgery of the IRCCS Carlo Besta Neurological Institute Foundation will be consecutively enrolled from the date of study approval for 24 months.",[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Carla Carozzi, M.D.","CONTACT","+39 02 2394","2420","carla.carozzi@istituto-besta.it",{"name":33,"role":28,"phone":34,"phoneExt":30,"email":35},"Marco Gemma, M.D.","+ 39 02 2394","marco.gemma@istituto-besta.it",[37],{"facility":38,"status":39,"city":40,"state":20,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fondazione IRCCS Istituto Neurologico Carlo Besta","RECRUITING","Milan","20133","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],12.59836,42.78235,{"lat":48,"lon":47},[51,53,55],{"name":52,"role":28,"phone":34,"phoneExt":30,"email":31},"Carla Carozzi, MD",{"name":52,"role":54,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"name":56,"role":57,"phone":20,"phoneExt":20,"email":20},"Marco Gemma, MD","SUB_INVESTIGATOR",{"type":59,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100581017",false,"NCT06844838","FASt Track in Elective Neurosurgery: the Role of Low Propofol Bis-NOL Guided General Anaesthesia for Full, Early and Safe Awakening","FasTrack","Inclusion Criteria:\n\n* Patients with supra- and sub tentorial neurosurgical pathology who meet the following inclusion criteria will be enrolled:\n* Age greater than or equal to 18 years\n\nExclusion Criteria:\n\n* Psychiatric illness in history and\u002For taking psychotropic drugs\n* Glasgow Coma Score (GCS) \\\u003C 15\n* Presence of overt cognitive decline or speech disorders\n* Patients younger than 18 years of age\n* Intraoperative hypothermia (\\\u003C 36°)\n* Intraoperative hypotension (MAP \\\u003C 20% of baseline)","ALL","18 Years",{"count":69,"type":70},100,"ESTIMATED","OBSERVATIONAL","To evaluate the effect of intraoperative sedation dosage on awakening and recovery of consciousness after elective neurosurgical surgery.",[74],"Supratentorial Brain Tumor Surgery",[76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91],"General Anaesthesia","BIS","Bispectral Index","NOL","Nocipection Level","Neuroanesthesia","Target Colled Infusion TCI","Craniectomy","Awakening","ERAS","Fast Track","Propofol","Remifentanil","Pain","Nociception","RASS","2026-02-10",{"date":94,"type":95},"2026-02-11","ACTUAL",{"date":97,"type":95},"2024-01-19",{"date":99,"type":70},"2026-02-01",{"name":5,"class":6},1]