Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
NCT06982690 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 370
Last updated 2025-05-21
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.
Conditions
- NMIBC
- TURBT
- Bladder (Urothelial, Transitional Cell) Cancer
- Bladder Cancer Recurrence
- Anesthesia, General
- Anesthesia,Spinal
Interventions
- PROCEDURE
-
Spinal 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.
- PROCEDURE
-
General 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 & Collaborators
-
National Taiwan University Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-01
- Primary Completion
- 2029-11-30
- Completion
- 2029-11-30
Countries
- Taiwan
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