Anesthesia, General, Anesthesia,Spinal, Bladder Cancer Recurrence, Bladder (Urothelial, Transitional Cell) Cancer, NMIBC, TURBT
Conditions
Keywords
bladder cancer, general anesthesia, spinal anesthesia, recurrence, TURBT
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.
Interventions
PROCEDURESpinal Anesthesia
A total of 10-12 mg of 0.5% bupivacaine will be administered into the cerebrospinal fluid of the subarachnoid space using a 25-gauge Quincke spinal needle via an 18-gauge introducer (adjusted by body height). Midazolam (2-5 mg) may be used to decrease anxiety.
PROCEDUREGeneral Anesthesia
Induction will be performed with propofol (0.5-1.5 mg/kg) and fentanyl (1-2 µg/kg), and anesthesia will be maintained with sevoflurane (1-3 vol %) via a laryngeal mask or endotracheal intubation. Rocuronium (0.5-0.6 mg/kg) will be used for induction, maintenance and occurrence of obturator jerk.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recurrence in high risk NMIBC patients | From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks | The time to recurrence is defined as the number of days from TURBT to the day on which the subject presents with gross hematuria, positive urine cytology, all-risk bladder tumor relapse or newly diagnosed upper tract UC with pathological confirmation, radiographically detected tumor metastasis, or cancer-specific death beyond 90 days after diagnosis, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to event in high-risk NMIBC patients up to Week 104 | From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks | An event is defined as a composite variable reflecting the recurrence of a high-risk disease (any high-grade disease, any T1 tumor, multifocal disease, \>3 cm, variant histology, lymphovascular invasion, or CIS), disease progression or metastasis, BCG unresponsiveness, or cancer-specific death, whichever occurs first. |
Countries
Taiwan
Contacts
Primary ContactJeff Shih-Chieh Chueh, MD, PhD
Backup ContactChu-Wen Fang, MD, MMed
Outcome results
None listed