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

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.

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Patients with prior or concurrent UC involving the renal pelvis, ureter or urethra
• Patients with clinical evidence of MIBC or mUC
• Immunocompromised or immunosuppressed patients
• Patients with chronic use of anti-inflammatory agents or beta-blockers
• 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