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Not yet recruiting NCT06982690

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

No phase Interventional NMIBC TURBT Bladder (Urothelial, Transitional Cell) Cancer Bladder Cancer Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal Anesthesia, General Anesthesia.
Who it may be relevant to
Registry conditions: NMIBC, TURBT, Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Recurrence. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Impact of Anesthesia Modality on Recurrence and Progression in High-Risk Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial Comparing Spinal Versus General Anesthesia

Overview

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

  • 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.

Primary outcome measures

  • Time to recurrence in high risk NMIBC patients [Time frame: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks]
Secondary outcome measures (1)
  • Time to event in high-risk NMIBC patients up to Week 104 [Time frame: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Department of Urology, College of Medicine, National Taiwan University — Taipei

Publications

  • 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. PMID 41314851

Identifiers

NCT: NCT06982690 · 202411115RINE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗