Trials / Not Yet Recruiting
Not Yet RecruitingNCT06982690
Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 370 (estimated)
- Sponsor
- National Taiwan University Hospital · Academic / Other
- Sex
- All
- Age
- 20 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-08-01
- Primary completion
- 2029-11-30
- Completion
- 2029-11-30
- First posted
- 2025-05-21
- Last updated
- 2025-05-21
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT06982690. Inclusion in this directory is not an endorsement.