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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anesthesia | Placebo Comparator |
| |
| Spinal Anesthesia | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Anesthesia | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence in high risk NMIBC patients | 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. | From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to event in high-risk NMIBC patients up to Week 104 | 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. | From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeff Shih-Chieh Chueh, MD, PhD | Contact | +886-2312-3456 | 262135 | jeffchueh@gmail.com |
| Chu-Wen Fang, MD, MMed | Contact | +886-2312-3456 | 265728 | abao007@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, College of Medicine, National Taiwan University | Taipei | Taipei | 100 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41314851 | Derived | Fang CW, Shau WY, Fan SZ, Chueh JS. Comparison of spinal versus general anaesthesia in high-risk non-muscle invasive bladder cancer: study protocol for a randomised controlled trial. BMJ Open. 2025 Nov 28;15(11):e107824. doi: 10.1136/bmjopen-2025-107824. |
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|
| General Anesthesia | Procedure | 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. |
|
| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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