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

Surgery Bladder Cancer Cancer Recurrence Delirium Benzodiazepines

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

Inclusion Criteria4

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.

Exclusion Criteria8

Refuse to participate;
Emergent surgery;
Combined with other malignant tumors;
Use of benzodiazepines for 1 week within the last month before surgery;
Preoperative history of schizophrenia, epilepsy, parkinsonism or myasthenia gravis;
Inability to communicate in the preoperative period due to coma, profound dementia, language barrier, or end-stage disease;
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);
The purpose of surgery is to make a diagnosis or preoperative judgement is that tumor cannot be completely removed.

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.