Study On The Efficacy And Safety Of Remidazolam Tosilate And Propofol In Elderly Patients Undergoing Endoscopic Retrograde Cholangiopancreatography

Objective:With the increasing complexity of endoscopic retrograde cholangiopancreatography（ERCP）procedures,the stimulation brought by the operating process is becoming increasingly intense,and the depth of sedation required for surgery is also increasing.Elderly patients have poor tolerance to anesthesia.The purpose of this study is to explore the efficacy and safety of Remimazolam Tosilate（hereinafter referred to as Remimazolam）and Propofol for ERCP in elderly patients.Methods:260 patients who met the inclusion criteria for elective ERCP were randomly divided into two groups:RM（remidazolam）group（n=130）and PF（propofol）group（n=130）.After entering room,the vital signs of the two groups of patients were monitored,including electrocardiogram（ECG）,non-invasive blood pressure（NBP）,saturation of pulse oximetry（Sp O₂）,and bispectral index（BIS）.After positioning,a venous channel was established and oxygen was inhaled through a nasal catheter for 5 L/min.Patients in the RM group received sufentanil 0.1μg/kg and 0.2-0.3 mg/kg remidazolam were slowly injected intravenously to induce anesthesia until the patient’s BIS value was maintained at 40-60.Intraoperative infusion of remidazolam was maintained at a rate of 0.6 to 1.2 mg/（kg·h）.Patients in Group PF received sufentanil 0.1μg/kg and propofol 1.0-2.0mg/kg were slowly injected intravenously until the patient’s BIS value was maintained at 40-60.Intraoperative infusion of propofol was maintained at a rate of 4 to 12 mg/（kg·h）.The physiological indicators of the two groups of patients before anesthesia induction（T0）,after induction completion/surgery start（T1）,5 minutes after surgery start（T2）,10minutes after surgery start（T3）,15 minutes after surgery start（T4）,at surgery end（T5）,and at patient’s recovery（T6）were recorded.This includes mean arterial pressure（MAP）,heart rate（HR）,blood oxygen saturation（Sp O₂）,respiratory rate（RR）,and BIS values.Record the dose of norepinephrine,anesthesia induction time,awakening time,PACU time,and surgical time.Adverse events during and after surgery were recorded,including hypotension,respiratory depression,bradycardia,body movements,postoperative delirium（POD）,intraoperative awareness,and postoperative nausea and vomiting（PONV）.Record body movements,presence or absence of injection pain,pain scores at awakening,and patient and doctor satisfaction.Result:The general data of patients in the PF group and the RM group are comparable.In terms of respiratory rate（RR）,mean arterial pressure（MAP）,and heart rate（HR）,the RM group was relatively stable and higher than the PF group.Pulse oximetry（Sp O₂）between the two groups were no significant difference at each time point.There was no difference in BIS values between the two groups at various time points during surgery.Patients in the RM group had longer anesthesia induction time,recovery time,and PACU time.The incidence of injection pain in the PF group was higher than that in the RM group.There was no difference in body movement,PONV,and POD incidence between the two groups.There was no difference in patient satisfaction and postoperative pain scores between the two groups,and there was no difference in doctor satisfaction between the two groups.Neither group experienced severe hypoxemia requiring mechanical ventilation.Conclusion:Remimazolam can provide satisfactory sedation depth required for ERCP operation,its sedation effect is not inferior to that of propofol,and it provides higher safety.Its incidence of cardiovascular and respiratory adverse events is lower than that of propofol,and it maintains more stable vital signs during operation.