NCT04532606 Impact of Remimazolam on Prognosis After Bladder Cancer Surgery
| NCT ID | NCT04532606 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University First Hospital |
| Condition | Benzodiazepines |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,128 participants |
| Start Date | 2021-02-05 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,128 participants in total. It began in 2021-02-05 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Wang Dong-Xin, MD, PhD
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT04532606 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Benzodiazepines. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04532606 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04532606 currently recruiting?
Yes, NCT04532606 is actively recruiting participants. Contact the research team at wangdongxin@hotmail.com for enrollment information.
Where is the NCT04532606 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijin, China, Guiyang, China and 2 additional locations.
Who is sponsoring the NCT04532606 clinical trial?
NCT04532606 is sponsored by Peking University First Hospital. The principal investigator is Wang Dong-Xin, MD, PhD at Peking University First Hospital. The trial plans to enroll 1,128 participants.