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Effect of Remimazolam on Hypoxemia and/or Hypotension in Prostate Biopsy
Sponsor: RenJi Hospital
Summary
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.
Official title: Effect of Remimazolam Sedation on Composite Adverse Events in Elderly Patients Undergoing Prostate Biopsy: A Prospective Multicenter Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
65 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1146
Start Date
2026-10-08
Completion Date
2027-07-01
Last Updated
2026-10-08
Healthy Volunteers
No
Conditions
Interventions
Using remimazolam for sedation during prostate biopsy
Administer 0.2mg/kg remimazolam, with the infusion time exceeding 10 seconds. Once the subject reaches a sufficient level of sedation (MOAA/S score ≤ 1), the operating doctor performs local infiltration anesthesia at the perineal puncture site with 5-10ml of 2% lidocaine, and then begins the prostate puncture procedure.
Administer 1.5mg/kg of propofol for sedation
Administer 1.5mg/kg of propofol, with the injection time exceeding 10 seconds. Once the subject reaches a sufficient level of sedation (MOAA/S score ≤ 1), the operating doctor performs local infiltration anesthesia at the perineal puncture site with 2% lidocaine, and then begins the prostate puncture procedure.