Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial (NCT06982690) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
Taiwan370 participantsStarted 2025-08-01
Plain-language 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.
Who can participate
Age range20 Years – 80 Years
SexALL
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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 …
What they're measuring
1
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