Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT04532606
Recruiting Phase 4

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)

Remimazolam →Propofol →

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
No
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)

FacilityCityRegionStatus
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

More Peking University First Hospital trials in China

Dexmedetomidine-esketamine Combination and Chronic Postsurgical Pain After Spinal Surgery Starting soon
Neoadjuvant Disitamab Vedotin, Toripalimab, and Radiotherapy for High-risk UTUC ( LUXUS07.1 ) Starting soon
Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease Recruiting
Intranasal Dexmedetomidine-esketamine Combination and Postoperative Cognitive Recovery in Older Patients Starting soon
Targeted Temperature Management on Delayed Neurocognitive Recovery in Older Patients After Major Cancer Surgery Starting soon

Other trials for the same condition

Comparison of the Efficacy and Safety of Fixed-rate Basal Infusion Mode and Time-programmed Decremental Background Infusion Mode of Intravenous PCA Following Mixed Surgery Recruiting
Endoscopic Surgery vs. Intensity Modulated Radiotherapy for Stage I Nasopharyngeal Carcinoma. Recruiting
Urinary Cell-Free DNA Liquid Biopsy for Urothelial Cancer Diagnosis and Origin Identification Recruiting
Evaluating the Efficacy of Neoadjuvant Chemotherapy Drugs Based on Organoid Technology Recruiting
Neoadjuvant Adebrelimab Plus Etoposide and Cisplatin in Neuroendocrine Bladder Carcinoma Recruiting
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