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

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.

Gastroscopy sedation: clinical trial comparing propofol and sufentanil with or without remimazolam.

BACKGROUND: Propofol-sufentanil is often used in clinical anesthesia for patients undergoing sedative gastroscopy, but there are still adverse events such as longer recovery time, respiratory depression and higher doses of propofol etc. This study was to evaluate the sedative effect of remimazolam-propofol-sufentanil in sedative gastroscopy. METHODS: Patients who were going to have gastroscopy examination were randomly divided into two groups: group RM (remimazolam-propofol-sufentanil group) and group PR (propofol-sufentanil group). Patients of each group were anesthetized according to the corresponding anesthesia procedure, and all observation indices were recorded. RESULTS: In the RM group, there were only small and unsignificant changes in the values of SBP, HR, RR and SpO2 after anesthesia (P>0.05), while the values of SBP, HR, RR and SpO2 in the PR group at each time point after anesthesia were significantly lower than those at T0, and the values of SBP and RR at T2, T3 and T4 were also significantly lower than those at T1 (P<0.05). The dosage of propofol (38±9 mg) in the RM group was significantly less than that (115±15 mg) in the PR group, meanwhile the anesthesia time (8.4±1.6 min), awakening time (2.9±0.8 min), discharge time (6.7±3.1 min) of the RM group were also significantly shorter than those of the PR group (14.5±3.3, 8.7±1.9, 12.4±3.6 min) (P<0.05), but there was no statistical significance between the two groups in other indices (P>0.05). CONCLUSIONS: In clinical practice, remimazolam-propofol-sufentanil sedative scheme has more advantages than propofol-sufentanil sedative scheme.