Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

Recruiting now · Phase 4

Conditions studied: Benzodiazepines, Bladder Cancer, Delirium, Surgery, Cancer Recurrence

In brief

Bladder cancer is one of the most common genitourinary cancers. Transurethral resection of bladder tumor (TURBT) is the standard therapy for nonmuscle invasive bladder cancer. However, patients after TURBT are at risk for recurrence and progression. Benzodiazepines are proved to inhibit proliferation of multiple types of cancer cells in vitro. Delirium is an acute onset and transient cerebral dysfunction and is associated with worse outcomes. Previous studies indicated that benzodiazepines increase incidence of postoperative delirium. Remimazolam is a new benzodiazepine with rapid onset and ultra-short activity. The aims of this study are to explore the impact of remimazolam for general anesthesia on emergency delirium and recurrence-free survival in patients undergoing bladder cancer surgery.

Key facts

Study ID

NCT04532606

Run by

Peking University First Hospital

People needed

1128

Starts

2021-02-05

Expected to finish

2026-10-01

Last updated by the study team

2025-07-30

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥50 years and <90 years;
• Preoperative diagnosis is non-muscle-invasive bladder cancer(Ta-T1);
• Scheduled to undergo transurethral resection of bladder tumor;
• Agree to participate, and provide written informed consent.

You may not qualify if…

• Refuse to participate;
• Emergent surgery;
• Combined with other malignant tumors;
• Use of benzodiazepines for 1 week within the last month before surgery;
• Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
• Inability to communicate in the preoperative period due to coma, profound dementia, language barrier, or end-stage disease;
• 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);
• The purpose of surgery is to make a diagnosis or preoperative judgement is that tumor cannot be completely removed.

Where it is running

• Beijing Tsinghua Chang Gung Hospital — Beijing, Beijing Municipality, China (enrolling)
• The Sixth Medical Center of PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)
• Peking University First Hospital — Beijin, Bejing, China (enrolling)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (enrolling)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (enrolling)
• Shanghai 10th People's Hospital — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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