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

National Taiwan University

Status

Not yet enrolling

Conditions

Anesthesia, General

Bladder Cancer Recurrence

NMIBC

TURBT

Anesthesia,Spinal

Bladder (Urothelial, Transitional Cell) Cancer

Treatments

Procedure: Spinal Anesthesia

Procedure: General Anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT06982690

202411115RINE

Details and patient eligibility

About

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.

Enrollment

370 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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