Clinical Trial Comparing Remimazolam with Propofol during Intravenous Anesthesia: A Prospective Randomised Clinical Trial

Abstract

Background and Objective: Remimazolam is a water-soluble sedative-anesthetic with short-acting properties and less hemodynamic effects. Currently, it is primarily used for gastroenteroscopy sedation. The aim of this study is to investigate the effectiveness and safety of Remimazolam as an alternative intravenous anesthetic agent in surgical patients, in order to expand clinical options beyond Propofol. Methods: Eighty patients aged 20-69 and classified as an American Society of Anesthesiologists physical status I-II were randomly assigned to either the Remimazolam group (RM group) or the Propofol group (PR group) for anesthesia induction and maintenance. Hemodynamics and Bispectral Index (BIS) were recorded before and after anesthesia, along with other relevant indices such as the time, to loss of consciousness (LoC), operation time, anesthesia time, awakening time, the number of cases of injection site pain. Additionally, the Ramsay sedation score, intraoperative awareness, dreaming, and postoperative adverse events were also assessed. Results: After anesthesia, both groups experienced a significant decrease in blood pressure compared to baseline values, however, the reduction in blood pressure was less significant in the RM group than in the PR group (P<0.05). The heart rate of patients in the RM group remained relatively stable at all time points. There were significantly more cases of injection site pain and use of pressor or atropine during operation observed in the PR group compared to the RM group (P<0.05). There were no significant differences between the two groups in terms of time to loss of consciousness, anesthesia time, operation time, awakening time, and intraoperative awareness (P>0.05). However, at 5 and 30 minutes after awakening, the Ramsay sedation score was significantly better in the RM group compared to the PR group (P<0.05). Conclusion: When remimazolam is used for intravenous anesthesia induction and maintenance, it can achieve a favorable anesthetic effect while maintaining a relatively stable blood pressure and heart rate. Patients experience shorter awakening times (8.3±3.7 min), better awakening quality (5min Ramsay sedation score is 2 points ), and no intraoperative awareness. Trial Registration Number: AF SOP/3.6-01/5.1.