Clinical trial NCT06982690: Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: NMIBC
TURBT
Bladder (Urothelial, Transitional Cell) Cancer
Bladder Cancer Recurrence
Anesthesia, General
Anesthesia,Spinal
Keywords: bladder cancer
general anesthesia
spinal anesthesia
recurrence
TURBT
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 370
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Time to recurrence in high risk NMIBC patients
timeFrame: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks
Secondary outcomes:
measure: Time to event in high-risk NMIBC patients up to Week 104
timeFrame: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Urology, College of Medicine, National Taiwan University
Study officials:
References: