Study On Application Of Remazolam Tosylate In Painless Artificial Abortion

【Background】According to the latest data from the National Bureau of Statistics,The total population of China increased by 480,000 compared with 2020.of which the birth population will reach 10.62 million.Artificial abortion surgery more than 9 million times.China has a large number of abortions every year.According to the data of China Health Statistical Yearbook（2020）,the abortion rate in China has been rising since 2017.In 2019,the total number of abortions in China has exceeded 9.762 million,an increase of 0.23%compared with 2018^[1].According to the latest report,the number of induced abortions in China has remained at more than 9.5 million in the past five years^[2].Artificial abortion has become a remedy for most women’s contraceptive failure.Traditional abortion surgery can lead to severe pain and discomfort,and fear,strμggle and other conditions may lead to uterine perforation,incomplete uterine aspiration or other complications during the operation.Painless abortion is a safe and comfortable abortion technique,which allows patients to complete abortions completely painlessly and has been widely used.Remazolam tosylate has unique pharmacological effects.It can efficiently regulateγ-aminobutyric acid receptors to achieve therapeutic purposes.In recent years,it has been widely used in the induction of general anesthesia in adults,sedation of outpatient gastrointestinal endoscopy and ICU sedation due to its unique pharmacological and pharmacokinetic characteristics,including faster onset and elimination,shorter half-life than midazolam and dexmedetomidine,lower risk of cardiovascular and respiratory depression than propofol,and the availability of antagonists.At present,there is not enoμgh research evidence to prove the efficacy of remazolam tosylate in painless abortion.Therefore,the purpose of this study was to investigate the ED₅₀of remazolam tosylate combined with fentanyl in abortion and to compare the application effect of propofol in abortion.It is helpful to find safer and more effective drμgs for painless abortion,so as to improve the comfort and safety of patients.【Objective】1.The ED₅₀of remazolam combined with fentanyl in induced abortion was measured to explore its pharmacological characteristics.2.Comparison of the superiority of remazolam tosylate and propofol in painless artificial abortion.【Methods】Part Ⅰ:The ED₅₀of remazolam combined with fentanyl in induced abortion was measured.32 From September 2021 to December 2021 our hospital chose patients who had experienced a painless abortion.A Sequential technique altered was implemented.The dose gradient was 0.01 mg/kg.Fentanyl 1μg/kg（0.1 mg/branch+0.9%normal saline 18ml diluted to 5μg/ml）was intravenously injected within 1 minute.In a mere 1 minute,an intravenous injection of remazolam tosylate(0.20 mg/kg remazolam,（36 mg/branch+0.9%normal saline 36ml,diluted to 1mg/ml）was administered at the initial dose.The effective standard of anesthesia was determined by whether the patient had any body movement during the procedure.If no body movement reaction occurs,the anesthesia is effective,that is,negative;the next patient’s dose of ramazolam was reduced by 0.01 mg/kg.The following patient’s anesthesia was still effective,and the dose of ramazolam in the third patient was reduced by 0.01 mg/kg.On the contrary,the dose of remazolam increased by 0.01mg/kg.After 6 reentrys from negative to positive,the experiment was terminated.At the time of admission,the mean arterial pressure（MAP）,electrocardiogram（ECG）,heart rate（HR）,arterial oxygen saturation（SPO₂）,MOAA/_Sscore（T₂,T₆）and awake time were documented,1 min after fentanyl administration（T₁）.1 Following remazolam（T₂）,3 minutes after operation（T₃）,5 minutes after operation（T₄）,10minutes after operation（T₅）and being awake（T₆）Additional propofol（slowly inject in 1 minute）.Only one patient complained of dizziness when awake and did not use drμg treatment.All patients had no injection pain and no abnormality in the electrocardiogram monitor..Part Ⅱ:According to the results of the first part of the study,the ED₅₀of remazolam tosylate combined with fentanyl in inhibiting body movement during artificial abortion was 0.20 mg/kg.Exploring and contrasting the impact of remazolam tosylate and propofol in artificial abortion.62 From February 2022 to April 2022 our hospital chose those who had experienced a painless abortion.Randomly,31 cases were split into two distinct groups:the remazolam+fentanyl group（RF group）and the propofol+fentanyl group（PF group）.RF group was intravenously injected with remazolam 0.26 mg/kg(1.3 ED₅₀)+fentanyl 1μg/kg,PF group was intravenously injected with propofol emulsion injection 2 mg/kg+fentanyl 1μg/kg,and propofol 1 mg/kg was given according to the patient’s body movement and the length of operation.The mean arterial pressure（MAP）,heart rate（HR）,finger pulse oxygen saturation（Sp O₂）,Narcotrend index,MOAA/s score,and awake time-all of these are taken into account.According to the patient’s body movement and the length of operation,propofol 1 mg/kg was given as a remedial sedative effect.The injection rate of all drugs was consistent with the experimental steps in the first part.The heart rate（HR）,mean arterial pressure（MAP）,finger pulse oxygen saturation（Sp O₂）,Narcotrend index,MOAA/s score,awake time,remedial sedation,dizziness,headache,nausea and vomiting,injection pain,respiratory depression,circulatory depression,abortion syndrome,dreaming and intraoperative awareness of adverse reactions were observed and compared between the two groups at each time point.【Results】1.The results of this study showed that among the 32 patients,16 were positive and 16 were negative.Compared with T₀,there was no significant change in Sp O₂at T₂（P>0.05）.The MAP and MOAA/s scores at T₂were lower than those at T₀（P<0.05）.The average awake time of patients was between 1.28±0.68 min.Only one patient complained of dizziness when awake and did not use drμg treatment.All patients had no injection pain and no abnormality in the electrocardiogram monitor.2.A total of 62 patients were included.There was no significant difference in age,weight and gestational age between the two groups（P>0.05）.The success rate of sedation in RF group and PF group was 100%.Compared with the PF group,the RF group had more cases of additional anesthetic drμgs,but the recovery time was shorter,and the difference was statistically significant（P<0.05）.There was no significant difference in the incidence of dizziness,headache,nausea and vomiting,respiratory depression,circulatory depression,abortion syndrome,dream occurrence and intraoperative awareness between the two groups（P>0.05）.However,compared with PF group,the incidence of injection pain,dream occurrence and circulatory depression in RF group was lower（P<0.05）.Compared with T0,the Narcotrend values of RF group and PF group at T₂,T₃,T₄and T₅were significantly lower（P<0.05）,which could meet the requirements of clinical sedation.At T₂,T₃and T₄,the Narcotrend value of PF group was significantly lower than that of RF group（P<0.05）.Compared with T₀time point,the MOAA/s score at T₂and T₃time points decreased significantly,and the difference was statistically significant（P<0.05）.At T₃time point,the MOAA/s score of PF group was significantly lower than that of RF group（P<0.05）.In RF group and PF group,compared with T₀,there was no significant decrease in SPO₂at T₁,T₂,T₃,T₄,T₅and T₆（P>0.05）,and the difference was not statistically significant.In RF group and PF group,compared with T₀time point,MAP decreased at T₂,T₃,T₄and T₆time points.At T₂,T₃,T₄and T₆,compared with the RF group,the MAP value of the PF group decreased more significantly（P<0.05）.In RF group and PF group,HR decreased at T₂,T₃,T₄and T₆compared with T₀time point.At T₄time point,compared with RF group,HR in PF group decreased significantly（P<0.05）.【Conclusion】1.The ED₅₀of remazoalm besylate combined with fentanyl in inhibiting body movement during abortion was 0.20 mg/kg,and the 95%confidence interval（CI）was 0.19-0.21 mg/kg.2.Remazolam and propofol,both anesthetics for painless abortion,are less likely to cause adverse reactions than propofol,and the recovery process is quick and complete.Therefore,remazolam is expected to become a feasible alternative to propofol in painless abortion,and more safe and effective.