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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · May 13, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the best way to use anesthesia during surgery for patients with a specific type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). The study aims to see if spinal anesthesia (which numbs the lower part of the body) is more effective than general anesthesia (which puts you to sleep) in delaying the return of cancer for patients who are at higher risk. The trial will follow participants for up to 104 weeks after their surgery, known as TURBT (Transurethral Resection of Bladder Tumor).

To participate in this trial, you must be at least 40 years old and have a suspected or newly diagnosed bladder cancer. You should be in generally good health, with no serious heart or lung conditions, and have normal kidney and liver function. Unfortunately, some people may not be eligible, such as those with a history of certain serious medical issues or allergies to specific anesthesia drugs. If you join the study, you can expect to receive one of the two types of anesthesia during your surgery and will be monitored closely to see how well it works in preventing cancer from coming back.

Gender

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Eligibility criteria

• 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