Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Collaborators: Beijing Tsinghua Chang Gung Hospital; Guizhou Provincial People's Hospital; Jiangsu Provincial People's Hospital; Shanghai 10th People's Hospital; The Sixth Medical Center of PLA General Hospital
• Treatments: Anesthetics; Propofol

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.