Anaesthesia, critical care & pain medicine · 2024
Comparison of the bispectral indices of patients receiving remimazolam and propofol for general anesthesia: a randomized crossover trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Yang Chen, Jiao Jing, Nie Yuyan, Shao Wenyu, Zhang Hongwei, Huang Shaoqiang
Аннотация
BACKGROUND: Remimazolam is a safe and effective new benzodiazepine sedative that has unique advantages in anesthesia induction and maintenance. The differences in the electroencephalogram bispectral index (BIS) during general anesthesia between propofol and remimazolam deserve further exploration.
METHODS: Single-center randomized crossover study. Patients who required multiple hysteroscopic surgery were randomly assigned to use remimazolam (0.27 mg/kg for induction and 1 mg/kg/h for maintenance) first and then propofol (2.0 mg/kg for induction and 6 mg/kg/h for maintenance) during hysteroscopic surgery again 3 months later, or in the opposite order. Both drugs were used at the latest ED95 for unconsciousness. The BIS values (primary endpoint), intraoperative conditions, and incidence of adverse reactions (secondary endpoints) were compared at each time point. BIS values were analyzed with a mixed model of repeated measurements (MMRM).
RESULTS: Seventeen patients completed the study. The lowest BIS value in the remimazolam regimen was significantly higher than that in the propofol regimen (p = 0.001). The MMRM analysis of the BIS values revealed significant differences between the regimens at each time point (p < 0.001). The intraoperative diastolic blood pressure and heart rate changes were smaller, the recovery was faster, and there were fewer adverse reactions and less injection pain, but a greater incidence of intraoperative body movement and hiccups, in the remimazolam regimen.
CONCLUSION: The trial indicated that remimazolam maintained a higher BIS level than propofol. The correlation between the BIS and the depth of anesthesia induced by remimazolam needs to be further studied.
TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov: ChiCTR2200064551.
METHODS: Single-center randomized crossover study. Patients who required multiple hysteroscopic surgery were randomly assigned to use remimazolam (0.27 mg/kg for induction and 1 mg/kg/h for maintenance) first and then propofol (2.0 mg/kg for induction and 6 mg/kg/h for maintenance) during hysteroscopic surgery again 3 months later, or in the opposite order. Both drugs were used at the latest ED95 for unconsciousness. The BIS values (primary endpoint), intraoperative conditions, and incidence of adverse reactions (secondary endpoints) were compared at each time point. BIS values were analyzed with a mixed model of repeated measurements (MMRM).
RESULTS: Seventeen patients completed the study. The lowest BIS value in the remimazolam regimen was significantly higher than that in the propofol regimen (p = 0.001). The MMRM analysis of the BIS values revealed significant differences between the regimens at each time point (p < 0.001). The intraoperative diastolic blood pressure and heart rate changes were smaller, the recovery was faster, and there were fewer adverse reactions and less injection pain, but a greater incidence of intraoperative body movement and hiccups, in the remimazolam regimen.
CONCLUSION: The trial indicated that remimazolam maintained a higher BIS level than propofol. The correlation between the BIS and the depth of anesthesia induced by remimazolam needs to be further studied.
TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov: ChiCTR2200064551.