RecruitingPhase 4NCT04532606

Impact of Remimazolam on Prognosis After Bladder Cancer Surgery

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


Sponsor

Peking University First Hospital

Enrollment

1,128 participants

Start Date

Feb 5, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether using a sedation drug called remimazolam during bladder tumor surgery affects patient recovery and long-term cancer outcomes compared to other sedation methods. **You may be eligible if...** - You are between 50 and 90 years old - You have been diagnosed with non-muscle-invasive bladder cancer (early-stage, not yet growing into the bladder muscle) - You are scheduled to have a procedure called transurethral resection of bladder tumor (TURBT) — a surgery done through the urethra - You agree to participate and have signed informed consent **You may NOT be eligible if...** - You need emergency surgery - You have another active cancer - You have used benzodiazepine medications recently - You have schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis - You have severe liver dysfunction or are in critical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemimazolam

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.

DRUGPropofol

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.


Locations(6)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

The Sixth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijin, Bejing, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, China

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NCT04532606


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