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

NCT06982690 | Not Yet Recruiting

• 1 other identifier: 202411115RINE
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bladder cancer; general anesthesia; spinal anesthesia; recurrence; TURBT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to event in high-risk NMIBC patients up to Week 104

  From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks

Study Arms (2)

General Anesthesia

PLACEBO COMPARATOR

Procedure: General Anesthesia

Spinal Anesthesia

ACTIVE COMPARATOR

Procedure: Spinal Anesthesia

Interventions

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.

Spinal Anesthesia

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.

General Anesthesia

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Urology, College of Medicine, National Taiwan University

Taipei, Taipei, 100, Taiwan

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Neoplasms; Urinary Bladder Neoplasms; Recurrence

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Jeff Shih-Chieh Chueh, MD, PhD

CONTACT

+886-2312-3456; jeffchueh@gmail.com

Chu-Wen Fang, MD, MMed

CONTACT

+886-2312-3456; abao007@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Urology at National Taiwan University Hospital

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: May 21, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: May 21, 2025

Record last verified: 2025-04

Locations

TW (1)