drugset / Trial / NCT06093971

Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy

NCT06093971 ↗

Completed 112 enrolled Yonsei University
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The investigators conduct a random assignment into either the remimazolam group or the propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1 mg/kg) or propofol (0.5 mg/kg) are given. The standard anesthesia procedure of our institution is followed, and blood pressure data recorded during the surgery is analyzed (mean arterial pressure \<65mmHg is defined as hypotension).

Timeline

Start
2023-11-17
Primary completion
2024-10-22
Completion
2024-10-22

Outcome

Missed primary endpoint

paper Induction with remimazolam did not reduce intraoperative hypotension risk compared with low-dose propofol in patients undergoing RALP who continued ARB therapy. PMID 41233396 ↗

paper The hypotension incidence did not differ significantly between groups during the entire anesthesia (87.5% vs. 89.3%, P > 0.999). PMID 41233396 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule 1 mg/kg —
Subject Remimazolam Small molecule 0.2 mg/kg —

Indications