Application Of Different Doses Of Remimazolam Besylate In Hysteroscopic Surgery

BackgroundRemimazolam,a novel Benzodiazepine sedative drug.Remimazolam besylate is a salt form of remimazolam,which has many advantages such as rapid onset and offset,slightly affects hemodynamic and respiratory inhibition,almost no injection pain,metabolized in the human body by carboxylesterase and no biological activity of metabolites.Hysteroscopy is now often utilized in routine gynecological operations and serves both diagnostic and therapeutic purposes.Until now,the studies of remimazolam besylate in hysteroscopic surgery are still limit,its safety and efficacy in hysteroscopic anesthesia need to be investigated and validated.ObjectiveTo investigate the best initial loading dose,and remimazepam besylate’s effectiveness and safety should be confirmed for hysteroscopic surgery.MethodsThis was a single-center,prospective,randomized,double-blind,parallelcontrolled trial.A total of 476 patients underwent_elective-ambulatory hysteroscopy with BMI:20-25 kg/m2 and ASAI-Ⅱ in our hospital were divided into 4 groups used by random number method,with 119 cases each.The I.V initial loading dose of remimazolam besylate were 7 mg(group A),9.5 mg(group B),12 mg(group C),and 14.5 mg(group D).The hysteroscopic surgery could be stared when the MOAA/S score was below 3.If the subject’s MOAA/S score was still above 3 after delivery,additional injectable remimazolam besylate 2.5 mg per time at an interval of not less than 2 min each for a total of ≤2 times.If the subject’s MOAA/S score was higher than 3 after giving 2 injections of remimazolam besylate,the sedation treatment was considered to have failed and propofol injection 10-20mg was given immediately for remedy.Subjects’ MOAA/S scores were recorded at 1,1.5,2,2.5,and 3 min after administration of the test drug,followed by continuous recording of subjects’MOAA/S scores at 1-min intervals until the subjects awoke at the conclusion of the procedure,then recording adverse events(bradycardia,hypotension,hypertension,respiratory depression,injection pain,etc.).Results1.This study had 467 individuals in total,9 cases were removed and 467 cases of data were statistically evaluated.The baseline clinical features between groups did not differ significantly(P>0.05).2.The success rates of subjects with MOAA/S scores ≤3 who could undergo hysteroscopic surgical access after administration of the initial loading dose of test drug without additional drugs in the four groups were 0.87%,8.40%,71.79%,and 93.04%,respectively.The success rates were statistically different between the four groups.All groups are significantly different by pairwise comparison(P<0.05).3.The time to start surgery after the first dose was significantly different between the four groups when compared between the two groups(p<0.05).In groups A and B,as well as between groups C and D,there was no discernible variation in the dose of additional remimazolam besylate administered throughout the surgery across the four groups.(P>0.05).The interval between the final dose and the subject’s waking was not significantly different(p>0.05)between Group A and Group B,and also between Group C and Group D.Substantial variations between Group B and Group C and Group B and Group D in the overall duration from the beginning of dosing to the end of the process(P<0.05).4.None of the four groups experienced adverse Events including bradycardia,hypotension,hypertension,and injection pain with test drug.Across the four groups,there was no discernible difference in the prevalence of respiratory depression(P>0.05).ConclusionRemimazolam besylate presented safe and effective sedative for hysteroscopy,and the optimal initial loading dose was 14.5 mg.