Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
NCT ID: NCT06982690
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
370 participants
INTERVENTIONAL
2025-08-01
2029-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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General Anesthesia
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.
Spinal Anesthesia
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
80 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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National Taiwan University Clinical Trial Center
Director, Department of Urology at National Taiwan University Hospital
Locations
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Department of Urology, College of Medicine, National Taiwan University
Taipei, Taipei, Taiwan
Countries
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Central Contacts
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Other Identifiers
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202411115RINE
Identifier Type: -
Identifier Source: org_study_id
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