Effects of Remimazolam on outcomes after bladder cancer surgery

Impact of Remimazolam Tosilate for General Anesthesia on Prognosis After Bladder Cancer Surgery: a Randomized Controlled Trial

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
• Enrollment: 1128 (estimated)
• Ages: 50 Years to 90 Years
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT04532606 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 50 to 90 years with a diagnosis of non-muscle-invasive bladder cancer scheduled for surgery.

Not a fit: Patients who may not benefit include those with critical illnesses, severe hepatic or renal dysfunction, or those undergoing emergency surgery.

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 performed: Previous studies have shown varying effects of benzodiazepines on cancer outcomes, but the specific use of remimazolam in this context is relatively novel.

Eligibility 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 this trial is running

Beijing, Beijing Municipality and 5 other locations

• 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

Conditions Benzodiazepines; Bladder Cancer; Delirium; Surgery; Cancer Recurrence; Remimazolam; Emergence Delirium; Recurrence-free Survival