Comparison Of The Safety And Efficacy Of Remimazolam And Propofol In Gastrointestinal Endoscopy Anesthesia

Objective:The 95%effective doses（ED95）of remimazolam and propofol in painless gastrointestinal endoscopy with a BIS value of 60 were determined respectively.To compare the efficacy and safety of equivalent doses of remimazolam and propofol for painless gastrointestinal endoscopy.Methods:Patients who were scheduled to undergo painless gastrointestinal endoscopy in our hospital from July to December 2021 were randomly selected.After entering the room,patients were placed in the left lateral decubitus position,venous access was established,and bispectral index,blood pressure,heart rate,and blood oxygen saturation were monitored.Oxygen was inhaled 4 L/min by the mask.Patients were given alfentanil 10 ug/kg intravenously.This study was divided into two parts:Part I:The continuous enrollment,upper and lower sequential method was adopted,with BIS value 60 was used as positive index.The dose gradient of the remimazolam group（RA group）is divided into 6 grades according to the proportional progression,and the initial dose is 0.14 mg/kg.If the response is negative,the next patient were given a higher dose,and the first test subject with a positive result was enrolled.After a positive result,the next patient was given a lower dose until a negative response occurs,and so on,until nine crossover pairs appear.The dose gradient of the propofol group（PA group）was also divided into 6 grades according to the proportional progression.The first dose was 1.3mg/kg,and the method was the same as that of the RA group.Binary regression probability analysis（Probit regression analysis）was used to calculate the doses of remimazolam and propofol that could achieve a BIS value of 60 in 95%of the subjects.Part II:A total of 240patients who planned to undergo painless gastroenteroscopy were divided into two groups（n=120）by random number scale:remimazolam group（RB group）,propofol group（PB group）.The patients in the RB group were slowly injected intravenously according to the ED95 dose of remimazolam determined in the first trial,and the patients in the PB group were slowly intravenously injected according to the ED95 dose of propofol determined in the first trial.When the patient’s BIS value reached 50-60,endoscopy began.If the patient’s BIS value did not reach 60 or the sedation was insufficient during the endoscopy,remimazolam 2.5 mg or propofol 0.5-1 mg/kg is added.Record the BP,ECG,and Sp O₂ of the patients（1）at the time of entering the room（T₀）,at the beginning of the operation（T₁）,2 minutes after the operation（T₂）,at the time of entering the recovery room（T₃）,and at the time of full recovery（T₄）;（2）Intraoperative adverse events Reaction:the occurrence of hypotension,bradycardia,low blood oxygen saturation,severe cough,body movement response,hiccups and injection pain;（3）Postoperative adverse reactions:postoperative dizziness,nausea,and vomiting;（4）Additional Interval time between drugs;（5）Time of complete awakening（the time from the patient entering the recovery room to fully awakening）;（6）Patient satisfaction and willingness to be tested again.Results:Part I:A total of 58 patients were included in the first part of the experiment,and there was no significant difference in general conditions such as gender,age,height,and weight between the two groups（P>0.05）.The ED95 of remimazolam was 0.249 mg/kg（95%CI:0.202-0.630 when the BIS value was 60 in patients pretreated with alfentanil 10μg/kg）by sequential method.),the ED95 of propofol was 1.578 mg/kg（95%CI:1.314-3.153）.Part II:A total of 240 patients were included in the second part of the experiment,with 120 patients in each group.There was no significant difference in general conditions between the two groups（P>0.05）.Comparison within groups:Compared with T0,the BP of T1-T4 in both groups decreased（P<0.05）,the HR of remimazolam group decreased at T1 and T2,and the HR of propofol group decreased in T1-T4.The BP and HR of both groups showed a trend of first decreasing and then increasing.Comparison between groups:Compared with propofol group,remimazolam group had higher BP at T1-T3 time points and higher HR at T1-T4 time points（P<0.05）.Compared with the propofol group,the remimazolam group had lower circulatory fluctuations and showed a tendency to recover earlier;blood oxygen saturation and the incidence of injection pain were lower,while bradycardia,hiccups,coughing,dizziness and nausea There was no significant difference in the incidence of vomiting（P>0.05）.Compared with the propofol group,there was no significant difference in the interval time of one additional drug in the remimazolam group（P>0.05）.The time to complete recovery was shorter in remimazolam group（6.75±3.56 vs.3.97±1.30）（P<0.05）.There was no significant difference in patient satisfaction and willingness to retest between the two groups（P>0.05）.Conclusions:In painless gastrointestinal endoscopy,the ED95 of remimazolam was 0.249mg/kg and the ED95 of propofol was 1.578 mg/kg when the BIS value was 60 in patients pretreated with alfentanil 10μg/kg.Compared with the equivalent dose of propofol,compared with the equivalent dose of propofol,remimazolam was more hemodynamically stable,had a lower incidence of respiratory depression and fewer adverse reactions,and was more safer for painless gastroenteroscopy.