[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630335":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":46,"locations":52,"responsibleParty":96,"collaborators":28,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":28,"enrollmentInfo":109,"targetDuration":28,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":120,"overallStatus":128,"whyStopped":28,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Ente Ospedaliero Ospedali Galliera","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"neuraxial anesthesia combined with sedation","ACTIVE_COMPARATOR","patients are submitted to laparoscopic or robotic abdominopelvic surgery with a neuraxial anesthesia combined with sedation.",[13,14],"Procedure: Neuraxial anesthesia","Drug: avoidance of GABAergic-drugs strategy",{"label":16,"type":10,"description":17,"interventionNames":18},"General anesthesia","patients are submitted to laparoscopic or robotic abdominopelvic surgery undergoing a general anesthesia.",[19,20,21],"Procedure: General Anesthesia","Drug: use of GABAergic-drugs","Procedure: mechanical ventilation (MV)",[23,29,33,38,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"PROCEDURE","Neuraxial anesthesia","patients undergo surgery with a neuraxial anesthesia based on spinal or epidural anesthesia using local anesthetics combined with sedation.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"General Anesthesia","patients undergo surgery with a general anesthesia using classical GABAergic-drugs.",[16],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"DRUG","avoidance of GABAergic-drugs strategy","Sedation based on dexmedetomidine and low dosage of ketamine, avoiding GABAergic-drugs",[9],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"use of GABAergic-drugs","General anesthesia using classical GABAergic-drugs such as propofol, remifentanil and rocuronium.",[16],{"type":24,"name":43,"description":44,"armGroupLabels":45,"otherNames":28},"mechanical ventilation (MV)","Abdomino-pelvic Surgery managed in general anesthesia needs orotracheal intubation and mechanical ventilation",[16],[47],{"name":48,"role":49,"phone":50,"phoneExt":28,"email":51},"Claudia Brusasco, MD, PhD","CONTACT","0039 3291185009","claudia.brusasco@galliera.it",[53,79],{"facility":54,"status":28,"city":55,"state":28,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"E.O. Ospedali Galliera","Genova","16128","Italy","IT",{"type":60,"coordinates":61},"Point",[62,63],11.87211,45.21604,{"lat":63,"lon":62},[66,68,71,73,75,77],{"name":48,"role":49,"phone":67,"phoneExt":28,"email":51},"00393291185009",{"name":69,"role":70,"phone":28,"phoneExt":28,"email":28},"Marco Micali, Md","SUB_INVESTIGATOR",{"name":48,"role":72,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"name":74,"role":70,"phone":28,"phoneExt":28,"email":28},"Federico Germinale, MD",{"name":76,"role":72,"phone":28,"phoneExt":28,"email":28},"Carlo Introini, Md",{"name":78,"role":70,"phone":28,"phoneExt":28,"email":28},"Maura Marcucci, MD, PhD",{"facility":80,"status":28,"city":81,"state":28,"zip":82,"country":57,"countryCode":58,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"AO di Circolo di Melegnano","Vizzolo Predabissi","20070",{"type":60,"coordinates":84},[85,86],9.34815,45.35587,{"lat":86,"lon":85},[89,93,94],{"name":90,"role":49,"phone":91,"phoneExt":28,"email":92},"Davide Vailati, MD","0039 0298052377","davide.vailati@asst-melegnano-martesana.it",{"name":90,"role":72,"phone":28,"phoneExt":28,"email":28},{"name":95,"role":70,"phone":28,"phoneExt":28,"email":28},"Benedetta Basta, MD",{"type":72,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Claudia Brusasco","MD PhD Anesthesiologist","100630335","awareness-neuraxial-versus-general-anesthesia-in-frail-patients-undergoing-laparoscopic-or-robotic-abdominopelvic-surgery-100630335",false,"NCT07486336","Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery.","Neuraxial Anesthesia Awareness Versus General Anesthesia in Frail Patients Undergoing Elective Laparoscopic or Robotic Abdominopelvic Surgery: A Pilot Randomized Controlled Trial.","SAFE-AWARENESS","Inclusion Criteria:\n\n* Age \\> 60 years\n* Willingness to participate in the study and written informed consent\n* ASA physical status \\> 2\n* Frailty score \\> 5 and\u002For AMT-10 \\\u003C 6\n* Laparoscopic or robotic major elective abdominopelvic surgery\n\nExclusion Criteria:\n\n* Patients undergoing open (laparotomic) or emergency surgery, or presenting contraindications to central locoregional (neuraxial) anesthesia, specifically:\n\n  * coagulation disorders\n  * severe spinal deformities\n  * known allergy to local anesthetics\n  * severe aortic stenosis\n  * systemic sepsis\n  * infection at the puncture site\n* Any systemic disease that, in the investigator's judgment, is not compatible with participation in the study","ALL","60 Years",{"count":110,"type":111},100,"ESTIMATED","INTERVENTIONAL",[114],"NA","This is a bicentric, prospective, non-pharmacological, randomized study designed to compare the efficacy and safety of awake neuraxial anesthesia with sedation versus general anesthesia in frail patients undergoing elective major laparoscopic or robotic abdominopelvic surgery.\n\nA total of 100 frail patients aged over 60 years, with ASA physical status \\>2 and evidence of frailty and\u002For cognitive vulnerability, will be randomized to receive either standard general anesthesia with mechanical ventilation or thoracic neuraxial anesthesia combined with non-GABAergic sedation while maintaining spontaneous breathing.\n\nThe primary objective is to evaluate the feasibility in terms of recruitment of a RCT conducted in a population of frail or cognitively impaired patients undergoing major laparoscopic abdominal surgery, randomized to a neuraxial or general anesthetic approach in which the effects on the onset of postoperative delirium and postoperative cognitive dysfunction (POCD) will be determined. Secondary outcomes include the occurrence of postoperative organ dysfunction (respiratory, cardiovascular, renal, and metabolic), length of hospital stay, time to recovery after surgery, and postoperative mortality.\n\nPatients will undergo comprehensive perioperative clinical, laboratory, and ultrasound assessments, including lung and renal ultrasound evaluations. Neurological and functional status will be assessed during hospitalization, at 1 month, and via telephone follow-up at 1 year after surgery.\n\nThe aim of the study is to evaluate the feasibility and safety of performing two different anesthetic techniques on fragile patients.",[117,118,119],"Fraily","Abdominal Surgery","Postoperative Cognitive Dysfunction (POCD)",[121,122,123,124,125,126,127],"neuraxial anesthesia","awake surgery","frailty","postoperative delirium","cognitive outcomes","perioperative medicine","enhanced recovery after surgery","NOT_YET_RECRUITING","2026-03-17",{"date":131,"type":132},"2026-03-20","ACTUAL",{"date":134,"type":111},"2026-09-01",{"date":136,"type":111},"2029-01-01",{"name":5,"class":6},2]