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NCT Number: NCT06982690

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

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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Key information

Conditions

NMIBC Anesthesia, General Anesthesia,Spinal Bladder (Urothelial, Transitional Cell) Cancer Bladder Cancer Recurrence Carcinoma Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence TURBT Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Urology, College of Medicine, National Taiwan University

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

    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 outcomes

  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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chu-Wen Fang, MD, MMed

CONTACT

[email protected]

+886-2312-3456 ext. 265728

Jeff Shih-Chieh Chueh, MD, PhD

CONTACT

[email protected]

+886-2312-3456 ext. 262135

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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