Effects of Remimazolam on outcomes after bladder cancer surgery
Official title: Impact of Remimazolam Tosilate for General Anesthesia on Prognosis After Bladder Cancer Surgery: a Randomized Controlled Trial
Run by Peking University First Hospital · NCT04532606 · Data updated 2026-11-12
This study tests whether a new anesthesia called remimazolam can improve recovery and reduce complications for patients having surgery for bladder cancer compared to traditional anesthetics.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Enrollment | 1128 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 6 sites (Beijing, Beijing Municipality and 5 other locations) |
| Status | Recruiting |
| Started | February 5, 2021 |
| Main results expected | October 2025 |
| Study ends | October 2026 |
| Registry record updated | July 30, 2025 |
| Trial ID | NCT04532606 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 50 to 90 years with a diagnosis of non-muscle-invasive bladder cancer scheduled for surgery.
✕Probably not a fit
Patients who may not benefit include those with critical illnesses, severe hepatic or renal dysfunction, or those undergoing emergency surgery.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of remimazolam, a new benzodiazepine, on postoperative outcomes in patients undergoing transurethral resection of bladder tumors for non-muscle-invasive bladder cancer. The research focuses on how remimazolam affects the incidence of emergence delirium and recurrence-free survival compared to traditional anesthetics like propofol. By examining these outcomes, the study aims to provide insights into the potential benefits of using remimazolam in surgical settings for bladder cancer patients.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative recovery and reduced cancer recurrence rates for bladder cancer patients.
How similar studies have gone: Previous studies have shown varying effects of benzodiazepines on cancer outcomes, but the specific use of remimazolam in this context is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥50 years and \<90 years; 2. Preoperative diagnosis is non-muscle-invasive bladder cancer(Ta-T1); 3. Scheduled to undergo transurethral resection of bladder tumor; 4. Agree to participate, and provide written informed consent. Exclusion Criteria: 1. Refuse to participate; 2. Emergent surgery; 3. Combined with other malignant tumors; 4. Use of benzodiazepines for 1 week within the last month before surgery; 5. Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis; 6. Inability to communicate in the preoperative period due to coma, profound dementia, language barrier, or end-stage disease; 7. Critical illness (preoperative American Society of Anesthesiologists physical status classification ≥IV), severe hepatic dysfunction (Child-Pugh class C), or severe renal dysfunction (undergoing dialysis before surgery); 8. The purpose of surgery is to make a diagnosis or preoperative judgement is that tumor cannot be completely removed.
Where it's running
-
Beijing Tsinghua Chang Gung Hospital
Beijing, Beijing Municipality, China Recruiting -
The Sixth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China Recruiting -
Peking University First Hospital
Beijin, Bejing, China Recruiting -
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China Recruiting -
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China Recruiting -
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Wang Dong-Xin, MD, PhD — Peking University First Hospital
- Study coordinator: Wang Dong-Xin, MD, PhD
- Email: wangdongxin@hotmail.com
- Phone: 86 10 83572784
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.