Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

NCT04532606 · tracked via the Priya Life Science China tracker

Sponsor

Peking University First Hospital

Phase

Phase 4

Started

2021-02-05

Last updated

2025-07-30

Condition(s) studied

BenzodiazepinesBladder CancerDeliriumSurgeryCancer Recurrence

Investigational drug(s) / intervention(s)

RemimazolamPropofol

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.

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.

Study 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

Sex

ALL

Min age

50 Years

Max age

90 Years

Healthy volunteers

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.

Primary outcome measure(s)

Incidence of emergence delirium (early). — Up to 2 hours during the stay in post-anesthesia care unit after surgery.
Emergence delirium is assessed with the Confusion Assessment Method for the Intensive Care Unit at 10 and 30 minutes after admission to the post-anesthesia care unit after surgery.
Recurrence-free survival (long-term). — Up to 3 years after surgery.
Time from surgery to recurrence/metastasis or all-cause death, whichever come first.

Trial sites (6)

Facility	City	Region	Status
Beijing Tsinghua Chang Gung Hospital	Beijing	Beijing Municipality	Recruiting
The Sixth Medical Center of PLA General Hospital	Beijing	Beijing Municipality	Recruiting
Peking University First Hospital	Beijin	Bejing	Recruiting
Guizhou Provincial People's Hospital	Guiyang	Guizhou	Recruiting
Jiangsu Provincial People's Hospital	Nanjing	Jiangsu	Recruiting
Shanghai 10th People's Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04532606 on ClinicalTrials.gov ↗ ← All trials in China