[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591612":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":38,"responsibleParty":45,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":73,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"National Taiwan University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"General Anesthesia","PLACEBO_COMPARATOR",null,[13],"Procedure: General Anesthesia",{"label":15,"type":16,"description":11,"interventionNames":17},"Spinal Anesthesia","ACTIVE_COMPARATOR",[18],"Procedure: Spinal Anesthesia",[20,24],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":11},"PROCEDURE","A total of 10-12 mg of 0.5% bupivacaine will be administered into the cerebrospinal fluid of the subarachnoid space using a 25-gauge Quincke spinal needle via an 18-gauge introducer (adjusted by body height). Midazolam (2-5 mg) may be used to decrease anxiety.",[15],{"type":21,"name":9,"description":25,"armGroupLabels":26,"otherNames":11},"Induction will be performed with propofol (0.5-1.5 mg\u002Fkg) and fentanyl (1-2 µg\u002Fkg), and anesthesia will be maintained with sevoflurane (1-3 vol %) via a laryngeal mask or endotracheal intubation. Rocuronium (0.5-0.6 mg\u002Fkg) will be used for induction, maintenance and occurrence of obturator jerk.",[9],[28,34],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Jeff Shih-Chieh Chueh, MD, PhD","CONTACT","+886-2312-3456","262135","jeffchueh@gmail.com",{"name":35,"role":30,"phone":31,"phoneExt":36,"email":37},"Chu-Wen Fang, MD, MMed","265728","abao007@gmail.com",[39],{"facility":40,"status":11,"city":41,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Department of Urology, College of Medicine, National Taiwan University","Taipei","100","Taiwan","TW",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","National Taiwan University Clinical Trial Center","Director, Department of Urology at National Taiwan University Hospital","100591612","anesthesia-modality-and-oncologic-outcomes-in-high-risk-nmibc-a-randomized-trial-100591612",false,"NCT06982690","Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial","Impact of Anesthesia Modality on Recurrence and Progression in High-Risk Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial Comparing Spinal Versus General Anesthesia","Inclusion Criteria:\n\n* Age ≥40 years for male subjects or postmenopausal female subjects\n* ECOG performance status 0-2\n* Patients with suspected or newly diagnosed UBUC\n* ASA I or II\n* Patients with any other adequately treated Stage I or II cancer except UC, from which the subject has been disease free for 5 years\n* Adequate renal function, defined as a serum creatinine (Cre) concentration ≤ the institutional ULN\n* Adequate hepatic function, defined as total bilirubin ≤ the institutional ULN and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ the institutional upper limit of normal (ULN)\n\nExclusion Criteria:\n\n* Patients with prior or concurrent UC involving the renal pelvis, ureter or urethra\n* Patients with clinical evidence of MIBC or mUC\n* Immunocompromised or immunosuppressed patients\n* Patients with chronic use of anti-inflammatory agents or beta-blockers\n* Patients with difficult airways or other significant cardiovascular comorbidities (severe aortic stenosis, significant pulmonary disease, CHF) who are intolerant to GA\n* Patients with elevated intracranial pressure (ICP), primarily due to intracranial mass and trauma or infection at the site of SA\n* Patients with a serious uncontrolled medical disorder (e.g., trauma, fracture) or active infection that would impair their ability to receive spinal or GA\n* Patients with known allergies to propofol, fentanyl, sevoflurane, or bupivacaine\n* Subjects with a known history or family history of malignant hyperthermia\n* Subjects with bleeding diathesis","ALL","20 Years","80 Years",{"count":60,"type":61},370,"ESTIMATED","INTERVENTIONAL",[64],"NA","To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT.",[67,68,69,70,71,72],"NMIBC","TURBT","Bladder (Urothelial, Transitional Cell) Cancer","Bladder Cancer Recurrence","Anesthesia, General","Anesthesia,Spinal",[74,75,76,77,68],"bladder cancer","general anesthesia","spinal anesthesia","recurrence","NOT_YET_RECRUITING","2025-05-13",{"date":81,"type":82},"2025-05-21","ACTUAL",{"date":84,"type":61},"2025-08-01",{"date":86,"type":61},"2029-11-30",{"name":5,"class":6},1]