Revista estadounidense de administración avanzada de fármacos Acceso abierto

Abstracto

Efficacy and Safety of Remimazolam Tosilate for General Anesthesia Induction and Maintenance in Elderly Patients: A Randomized, Controlled Study

Fei Yang1, Lideng Guo2,3, Xiawei Lai1,2, Zhijing Zhang2, Di Wang2,3, Shanpan Peng2, Haihui Xie1,2

Purpose: To evaluate the efficacy and safety of Remimazolam Tosilate (RT) for general anesthesia in elderly patients.

Methods: 66 patients aged 60 years to 80 years who were scheduled to undergo surgery were randomized into three groups: Group A (RT 6 mg/kg/h), group B (RT 12 mg/kg/h), or group C (propofol 2.0 mg/kg-2.5 mg/kg). Primary efficacy indicators (success rate of anesthesia sedation), secondary efficacy indicators (BIS value, anesthesia induction time, anesthesia awakening time), safety efficacy indicators (incidence of anesthetic hypotension; incidence of anesthetic hypoxemia, etc.) and Adverse Events (AEs) were routinely monitored.

Results: The success rate of anesthesia sedation was 95.45% in the 6 mg/kg/h RT group, and 100% in the 12 mg/kg/h RT and propofol groups. RT was noninferior to propofpl group (difference in rate -4.55%, 95% confidence interval (CI, -0.12; 0.03), meeting criteria for noninferiority). There were no significant differences in the time of anesthesia induction or incidence of bradycardia and hypotension among the three groups. However, compared with the propofol group, the awakening time in the RT groups was significantly shorter (P<0.05), less impact on heart rate, no injection pain, and significantly less norepinephrine usage (P<0.05). The intraoperative BIS values of the three groups were all maintained at 40-72, and no intraoperative awareness was found.

Conclusion: RT (6 mg kg/h and 12 mg kg/h) was well tolerated and noninferior to propofol with regard to efficacy in inducing general anesthesia in elderly patients. And there were no significant difference in the induction and maintenance of anesthesia between different doses of RT.