drugset / Trial / NCT05164146

The Comparison of Hypotension Incidence Between Remimazolam and Propofol in Hypertensive Patients Undergoing Neurosurgery

NCT05164146 ↗

Completed 100 enrolled Yonsei University
RandomizedParallel-groupSingle-blindTreatment

Summary

This study aims to find an excellent drug in terms of hemodynamic stability when comparing the propofol and remifentanil with the combined use of remimazolam and remifentanil. When the mean blood pressure falls by 20% or more from the baseline mean blood pressure, it is considered hypotension, and a vasopressor such as ephedrine, phenylephrine, or norpin is used to control the blood pressure to within 20% of the baseline blood pressure. If the blood pressure increases by 20% or more above the baseline mean blood pressure, nicardipine infusion or remimazolam, propofol or remifentanil should be increased to control the blood pressure.

Timeline

Start
2022-02-23
Primary completion
2022-08-10
Completion
2022-08-10

Outcome

Missed primary endpoint

paper The incidence of hypotension was higher in the propofol group (91.3%) than in the remimazolam group (85.4%; P = 0.057). PMID 38834996 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule — —
Subject Remimazolam Small molecule — —

Indications

No indication recorded.