Efficacy and safety of remimazolam for non-obese patients during anesthetic induction in cardiac surgery: study protocol for a multicenter randomized trial

Abstract

Background Valvular heart disease remains common in both developed and developing countries, and it requires timely surgical treatment when necessary. However, the stability of hemodynamics during anesthesia induction in patients undergoing valve replacement surgery is difficult to maintain due to their impaired cardiac function. Remimazolam, a novel and ultrashort-acting intravenous sedative-hypnotic, may be beneficial to stable hemodynamics, but the evidence is limited. Therefore, this study aims to evaluate the effect of remimazolam induction on hemodynamics compared with midazolam and etomidate in patients undergoing valve replacement surgery. Methods This is a prospective, multicenter randomized controlled trial (RCT). Three hundred and sixty-three non-obese adult patients aged 45 to 80 years old undergoing valve surgery with cardiopulmonary bypass will be randomly allocated to receive remimazolam tosilate, midazolam, or etomidate during anesthetic induction. The primary outcome is the incidence of hypotension within 20 min after the administration of investigated drugs. The hypotension is defined as systolic blood pressure (SBP) < 90 mmHg or a 30% reduction in SBP from baseline or the application of vasoactive drugs. Secondary outcomes include incidence of successful sedation, time to successful sedation, incidence of delirium and postoperative low cardiac output syndrome within 7 days after surgery, hospital mortality, mechanical ventilation time, ICU length of stay, and hospital length of stay. Discussion To our knowledge, this is the first prospective RCT to investigate the efficacy and safety of remimazolam induction in adult cardiac surgery compared with midazolam and etomidate. This study will provide important information on the application of remimazolam in cardiac surgery in the future. Trial registration Chinese Clinical Trial Registry chictr.org.cn ChiCTR2100050122. Registered on August 16, 2021.

Comparative Analysis of the Hemodynamic Effects of Remimazolam and Propofol During General Anesthesia: A Retrospective Study

“…However, this should not be a major problem for the pre- and post-induction comparison because the situations with tonic sympathetic activities were the same for both groups. Fifth, HR is easily varied and influenced by many factors, such as the external environment and circadian rhythms [ 33 ]. In addition, the amount of data acquired by measurement devices is large, making it easy for the analysis of HRV results to vary.…”

“…Remimazolam has been used in several cardiac surgeries owing to its hemodynamic stability [33][34][35]. It is necessary to consider the potential risks of noncardiac surgery for cardiac disease, as an increase in HR may increase the workload of the heart and lead to changes in the oxygen supply-demand balance of the myocardium, a decrease in coronary perfusion pressure, and the development of myocardial ischemia [36].…”

The safety and efficacy of anesthesia induction and maintenance with remimazolam besylateon in elderly patients undergoing ureteroscopic laser lithotripsy

“…Furthermore, remimazolam has been explored as an option for surgical anesthesia in patients with cardiovascular conditions and those classi ed as ASA class III. Adequate sedation and hemodynamic stabilization could be attained by administering appropriate dosages of vasoactive medications (21)(22)(23). In the current investigation, various doses of phenylephrine were administered to increase blood pressure based on the extent of the decrease in blood pressure.…”