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

Who is this study for? Adult patients with Non-Muscle Invasive Bladder Cancer that plan to undergo transurethral resection
What treatments are being studied? Remimazolam
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijin
Beijing Tsinghua Chang Gung Hospital
RECRUITING
Beijing
The Sixth Medical Center of PLA General Hospital
RECRUITING
Beijing
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
Jiangsu Provincial People's Hospital
RECRUITING
Nanjing
Shanghai 10th People's Hospital
RECRUITING
Shanghai
Contact Information
Primary
Wang Dong-Xin, MD, PhD
wangdongxin@hotmail.com
86 10 83572784
Backup
Zhang Yu-Xiu, MD
zhangyuxiu1992@163.com
+86 15201190755
Time Frame
Start Date: 2021-02-05
Estimated Completion Date: 2026-10
Participants
Target number of participants: 1128
Treatments
Experimental: Remimazolam group
Remimazolam is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain Bispectral Index (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.
Active_comparator: Propofol group
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 inhalation is provided when considered necessary.
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai 10th People's Hospital, Beijing Tsinghua Chang Gung Hospital, Guizhou Provincial People's Hospital, Jiangsu Provincial People's Hospital, Navy General Hospital, Beijing
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov