Effect of remimazolam tosylate compared with etomidate on hemodynamics in patients undergoing valve replacement surgery: study protocol for a randomized trial

Abstract Background: Patients with cardiac disease are prone to develop cardiovascular adverse events such as hypotension, hypertension and tachycardia during anesthesia induction. Therefore, hemodynamic stability is one of the most important concerns for induction of anaesthesia in patients undergoing cardiac surgery. Remimazolam tosylate is a new ultra-short-acting benzodiazepine agent, with the advantages of rapid onset and offset, minimal cardiorespiratory depression. We aim to compare the effect of remimazolam tosylate and etomidate for anesthesia induction on hemodynamics in patients undergoing valve replacement surgery.Methods/design: The trial is a prospective, randomized, double-blind, controlled, single-center trial to compare the effect of remimazolam tosylate and etomidate on hemodynamics in patients undergoing valve replacement surgery. 117 patients undergoing valve replacement surgery between January 1, 2022, and December 31, 2023 will be enrolled and randomly allocated into one of three groups: low-dose remimazolam group (Group LR), high-dose remimazolam group (Group HR) or etomidate group (Group E). The primary outcome is hemodynamic fluctuations during anesthesia induction (the difference between mean arterial pressure (MAP) to baselinee, ▲MAP, the difference between maximum or minimum heart rate (HR) and baseline, ▲HR). Secondary outcomes include the incidence of adverse cardiovascular events (hypotension, severe bradycardia, hypertention, tachycardia and arrhythmia), the cumulative doses of vasoactive drugs used per patient, incidence and degree of injection pain and myoclonus.Discussion: This research will determine the effectiveness and safety of remimazolam tosylate induction on hemodynamics in patients undergoing valve replacement surgery.Trial registration: www.chictr.org.cn identifier: ChiCTR2100052535 (17th Dec 2021, http://www.chictr.org.cn/).