Effect of Remimazolam on Hypoxemia and/or Hypotension in Prostate Biopsy

This study aims to investigate whether remimazolam, a novel benzodiazepine sedative, can reduce the composite incidence of hypotension and hypoxemia during prostate biopsy in elderly patients compared with propofol. This study is a multicenter prospective randomized controlled trial.Participants will be recruited from five centers: Renji Hospital (Shanghai), Sun Yat-sen University Cancer Center, Zhongda Hospital (Nanjing), Shenzhen Hospital of the Cancer Hospital (CAMS), and Liaoning Fangda General Hospital.Baseline data will be collected for all participants, including demographic information, comorbidities, concurrent medication use, and vital signs.A total of 1,146 eligible participants will be randomized in a 1:1 ratio to receive either remimazolam (experimental group) or propofol (control group). Intraoperative hypoxemia and hypotension will be recorded as the primary outcomes. Secondary outcomes will include other sedation-related adverse events and patient satisfaction, which will be evaluated to comprehensively assess the efficacy and safety profile of remimazolam.

Inclusion Criteria: * 65 years old ≤ age ≤ 80 years old; * undergo sedated transperineal prostate biopsy; * 18.5kg/m2 ≤ BMI\2 units of alcohol (1 unit = 360 mL beer or 45 mL liquor with 40% alcohol content or 150 mL grapes liquor); * allergies or contraindication to benzodiazepines, opioids, propofol; * use of benzodiazepines, propofol and opioid drugs within the past three months; * participated in other drug clinical trials in the past 3 months; * investigator's judgment as an unsuitable participant.