The Application Of Remimazolam In Painless Hysteroscopic Surgery And Analysis Of Patient Status Index:A Prospective,Double-Blind,Randomized Study

Objective:To evaluate the effectiveness and safety of remimazolam in painless hysteroscopic surgery compared with propofol,and to analyze the correlation and relevance of the Patient Status Index（PSI）and the Modified Observer’s Assessment of Alertness/S edation（MOAA/S）score.Methods:124 female patients who undergoing painless hysteroscopy were randomly assigned to three groups:Propofol group（group P）,Remimazolam group（group R）and Remimazolam Antagonist group（group RA）.5ug of Sufentanil and 8mg of ondansetron were administered intravenously 2-3 minutes before the trial drug was given.Patients in group P were given 2 mg/kg propofol intravenously and maintained at a dosage of 0.5 mg/kg/time according to operation and body movement.Patients in group R and group RA were given intravenous remimazolam0.2 mg/kg and a dosage of 2.5 mg/time was added according to operation and body movement.After the operation,Patients in group P and group R was given 5ml normal saline and in group RA was given 5ml flumazenil（0.5mg）.Sedation success was defined as completed the hysteroscopy without the need of remedial drugs.The change of mean arterial pressure（MAP）、heart rate（HR）、blood oxygen saturation（Sp O2）、MOAA/S score and PSI value were recorded in after admission（T₀）,2 minutes after anaesthesia（T₁）,the beginning of hysteroscopy（T₃）,the end of hysteroscopy（T₄）,fully alert（T₅）and 5 minutes after awake（T₆）.In addition,The dose of the experimental drug,the times and doses of the additional drugs,the number of sedation successful,the time of successful anaesthesia,PSI value reached a trough after the first dosage,the last administration to fully alert,from the end of the hysteroscopy to fully alert,in PACU,and the incidence of adverse events were recorded.Results:The average dose of propofol was about 140 mg in group P,the average use of remimazolam in Group R was about 18mg,and in group RA was about 19mg,Group R was treated with propofol 50 mg once and Group R was treated with propofol 60 mg once.The sedation success rate was 100%in group P,97.5%in Group R and 97.7%in group RA,with no significant difference in three groups（P>0.05）;The time from the last administration to fully alert,from the end of the hysteroscopy to fully alert and the time in PACU in group RA were shorter than that in group P and group R（P<0.01）,there were no difference between group P and group R（P>0.05）.At T₁,MAP、HR and Sp O₂ in group P were significantly lower than those in Group RA and group R（P<0.05）,There were no difference between Group RA and group R（P>0.05）.No serious adverse event or death occurred in the three groups.The total adverse event rate in group P was significantly higher than that in Group R and group RA（P<0.01）,There were no difference between Group R and group RA（P>0.05）.The rate of hypotension（SBP<90mm Hg）and oxygenation（SPO₂<93%）in group P was higher than that in Group R and Group RA（P<0.05）,The incidence of injection pain in group P was significantly higher than that in Group R and group RA（P<0.01）,There were no difference between Group R and group RA（P>0.05）.The scores of MOAA/S in Group P、Group R and Group RA were correlated with PSI value,the correlation coefficients were 0.865、0.699 and 0.637 respectively.Conclusion:Remimazolam,with a dose of 0.2mg/kg,can be safely and effectively used for sedation in painless hysteroscopic surgery,and it is safer and more comfortable than propofol;Flumazenil can effectively antagonize the sedative effects of remimazolam and shorten the recovery time and in-hospital time of patients;There was a moderate correlation between PSI and MOAA/s score in remimazolam,but the correlation was weaker than that of propofol;The PSI median value of remimazolam was 50 and propofol was 40 for loss of speech response and consciousness.