Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

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.

Conditions

• Benzodiazepines
• Bladder Cancer
• Delirium
• Surgery
• Cancer Recurrence

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.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital

  collaborator OTHER

• Navy General Hospital, Beijing

  collaborator OTHER

• Guizhou Provincial People's Hospital

  collaborator OTHER

• Jiangsu Provincial People's Hospital

  collaborator OTHER

• Shanghai 10th People's Hospital

  collaborator OTHER

• Peking University First Hospital

  lead OTHER

Principal Investigators

• Wang Dong-Xin, MD, PhD · Peking University First Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-05

Primary Completion

2025-10-31

Completion

2026-10-31

Countries

• China

Study Locations