A Comparison of Remimazolam versus Propofol on Blood Pressure Changes During Therapeutic Endoscopic Retrograde Cholangiopancreatography: A Randomized Controlled Trial.

Abstract

BACKGROUND Intraoperative hypotension is the most common adverse event in endoscopic retrograde cholangiopancreatography (ERCP) and is usually attributed to the vasodilatory effect of the anesthetic. The aim of this randomized controlled trial was to evaluate the impact of remimazolam versus propofol on blood pressure changes during the therapeutic ERCP procedure. METHODS Adult patients scheduled for elective therapeutic ERCP were randomized to receive either remimazolam or propofol anesthesia (40 patients in each group). The primary outcomes included the change in mean arterial pressure (MAP) during induction and the area under the baseline (AUB), calculated as the blood pressure below baseline multiplied by the duration, throughout the procedure. These measures, respectively, indicated the severity of blood pressure decrease during anesthesia induction and the overall impact of blood pressure changes throughout the procedure. Any incidences of hypotension, defined as MAP <65 mm Hg for at least 1 minute, were recorded. The recovery time and any adverse events were also reported. RESULTS The change in MAP after induction was smaller in the remimazolam group compared to the propofol group (-7.5 [-14.0 to 0] mm Hg vs -25.0 [-33.8 to -14.3] mm Hg), with a median difference of 17.0 mm Hg (95% confidence interval [CI], 12.0-22.0; P <.001). The AUB in the remimazolam group was less than in the propofol group (-373 [-82 to -854] mm Hg·min vs -705 [-272 to -1100] mm Hg·min), with a median difference of 255 mm Hg·min (95% CI, 29-477; P =.021). The incidence of hypotension was significantly lower for remimazolam than propofol (5% vs 30%; P =.006). There were no serious adverse events in either group. CONCLUSIONS Remimazolam may be considered as an alternative to propofol for general anesthesia during therapeutic ERCP procedures, with the potential advantage of stable hemodynamics.