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NOT YET RECRUITING
NCT07854197
NA

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

Sponsor: RenJi Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.