Overview

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.