Status:
NOT_YET_RECRUITING
Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
Lead Sponsor:
National Taiwan University Hospital
Conditions:
NMIBC
TURBT
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2029
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06982690
Start Date
August 1 2025
End Date
November 30 2029
Last Update
May 21 2025
Active Locations (1)
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1
Department of Urology, College of Medicine, National Taiwan University
Taipei, Taipei, Taiwan, 100