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RECRUITING
NCT04532606
PHASE4

Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1128

Start Date

2021-02-05

Completion Date

2026-10

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

DRUG

Remimazolam

Remimazolam is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane inhalation is provided when considered necessary.

DRUG

Propofol

Propofol is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane is provided when considered necessary.

Locations (6)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

The Sixth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijin, Bejing, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China