Clinical Study Of Remimazolam Besylate For Sedation In ICU Septic Patients With Invasive Mechanical Ventilation

As a new type of ultrashort-acting benzodiazepine sedative/anesthetic agent,remimazolam acts on theγ-aminobutyric acid type A receptor（GABAAR）,with the characteristics of faster onset of action,rapid metabolism,almost no accumulation,and little effect on respiratory and circulatory system.At present,it is mainly used in the procedure sedation for painless gastrointestinal endoscopy and the induction/maintenance of general anesthesia.The existing study results and the pharmacological characteristics of remimazolam show that remimazolam is expected to be an ideal sedative for septic patients in intensive care unit with invasive mechanical ventilation.Objective:To explore the safety and efficacy of remimazolam besylate in sedation treatment of septic patient with invasive mechanical ventilation in intensive care unit,and the effects of remimazolam besylate on inflammatory cytokines and immune levels in septic patients.Method:This study was a single-center,prospective,randomized,controlled study.From June 2022 to January 2023,a total of 36 septic patients who need invasive mechanical ventilate were enrolled in emergency intensive care unit（EICU）of the First Affiliated Hospital of Kunming Medical University.These patients were randomly divided into two groups:19 patients were given remimazolam besylate for sedation（group R）,and17 patients were given midazolam for sedation（group M）.All the patients were given remifentanil for analgesia,with critical care pain observation tool（CPOT）score no more than 2 points.In group R,a loading dose of 7mg of remimazolam besylate was given by intravenous injection within 1 minute,and a dose of 0.1-0.5 mg/（kg·h）was continuously pumped intravenously to maintain sedation.In group M,a loading dose of 0.3mg/kg of midazolam was given by intravenous injection within 1 minute,and a dose of 0.05mg/（kg·h）was continuously pumped intravenously to maintain sedation.The sedation target for both groups was a Richmond agitation-sedation scale（RASS）score of 0 to-4.The lowest heart rate,lowest mean arterial pressure,sequential organ failure assessment（SOFA）score,acute physiological and chronic health evaluation（APACHEII）score,Richmond agitation-sedation scale（RASS）score,critical care pain observation tool（CPOT）score,and changes in cytokines and immune levels were monitored and compared between the two groups from the first day to the third day of the experiment.Results:1.There were no significant differences in age,gender,source of Infection,APACHEII score on admission,SOFA score on admission,heart rate on admission,mean arterial pressure on admission,p H,Pa O2,Pa CO2,HCO3^-and lactic acid between the two groups（P>0.05）.2.Effectiveness:Both groups could achieve the preset sedation and analgesia goals during the trial.There was no significant difference in CPOT score and RASS score between the two groups（P>0.05）.There was no significant difference in effectiveness between the two groups.3.Safety:There were no significant differences in the minimum heart rate,minimum mean arterial pressure,arterial blood p H,arterial blood lactate level,arterial partial pressure of oxygen（Pa O₂）,arterial partial pressure of carbon dioxide（Pa CO₂）,oxygenation index（OI）,mechanical ventilation oxygen concentration（Fi O₂）,positive end-expiratory pressure（PEEP）between the two groups（P>0.05）.There was no significant difference in safety between the two groups.4.On the first day of the experiment,there was no significant difference in the absolute counts of CD4⁺and CD8⁺between the two groups（P>0.05）.On the third day of the experiment,the absolute values of CD4⁺and CD8⁺in the remimazolam group were significantly higher than those in the midazolam group（P<0.05）.Conclusion:Remimazolam besylate can be used to sedate septic patients with invasive mechanical ventilation in ICU.Remimazolam besylate has smaller effect on the patient’s cellular immune system.