Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial

Prior treatment

• Patients with prior or concurrent UC involving the renal pelvis, ureter or urethra

Other illness

• Patients with difficult airways or other significant cardiovascular comorbidities (severe aortic stenosis, significant pulmonary disease, CHF) who are intolerant to GA
• Patients with elevated intracranial pressure (ICP), primarily due to intracranial mass and trauma or infection at the site of SA
• Patients with a serious uncontrolled medical disorder (e.g., trauma, fracture) or active infection that would impair their ability to receive spinal or GA
• Patients with known allergies to propofol, fentanyl, sevoflurane, or bupivacaine
• Subjects with a known history or family history of malignant hyperthermia
• Subjects with bleeding diathesis

Other

• Patients with clinical evidence of MIBC or mUC
• Immunocompromised or immunosuppressed patients
• Patients with chronic use of anti-inflammatory agents or beta-blockers

• Age ≥40 years for male subjects or postmenopausal female subjects
• ECOG performance status 0-2
• Patients with suspected or newly diagnosed UBUC
• ASA I or II
• Patients with any other adequately treated Stage I or II cancer except UC, from which the subject has been disease free for 5 years
• Adequate renal function, defined as a serum creatinine (Cre) concentration ≤ the institutional ULN
• 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)