Feasibility And Safety Evaluation Of Remazolam Tosylate In Elderly Patients During Bronchoscopy

Objective To evaluate the feasibility and safety of remazolam tosylate in elderly patients undergoing fiberoptic bronchoscopy,in order to find a safe and feasible sedation method for elderly patients undergoing fiberoptic bronchoscopy.Methods This study is a single-center randomized controlled trial.A total of 105 elderly patients who were scheduled to undergo fiberoptic bronchoscopy in Hangzhou First People’s Hospital from December 2020 to August 2021 were selected,and the patients were divided into 3 groups（n=35）randomly by the random number table method.Group A（remazolam tosylate group）:intravenous injection of remazolam 0.2 mg/kg and fentanyl 0.5 μg/kg for sedation before examination;Group B（midazolam group）:intravenousinjection of midazolam0.075mg/kg and fentanyl 0.5 μg/kg for sedation before examination;Group C（control group）:routine tracheal mucosal surface spraying of lidocaine,no other treatment.Record the patients’ heart rate（HR）,blood pressure（BP）,blood oxygen saturation（SpO2）,end-expiratory carbon dioxide（PetCO2）,bispectral index（BIS）at the time of T0（after entering the room and breathing room air before anesthesia）,T1（the state after anesthesia induction under nasal cannula oxygen inhalation（oxygen flow 3-5L/min））,T2（when the fiberoptic bronchoscope was placed in the glottis）,T3（the end of the operation）,T4（at the time of awakening）;record drug onset time,operation time,recovery time;record the number of additional drug supplements;record intraoperative body movement and cough,hypoxemia and other adverse events;evaluate operators’ and patients’ satisfaction.Results A total of 105 patients were enrolled and 97 actual patients（34 patients in group A,30 patients in group B,and 33 patients in group C）were analyzed in the end.Compared with group C,MAP in group A was significantly decreased at T1,T2,T3,and T4（P<0.05）,and the difference was statistically significant.Compared with group B,MAP in group A was significantly decreased at T1 and T2.Compared with group C,MAP in group B was significantly decreased at T3 and T4.Compared with group C,HR in group A was significantly decreased at T3 and T4.There were no significant differences in SpO2or PetCO2 at each time point of T0,T1,T2,T3,and T4 among the three groups（all P>0.05）.Compared with group C,RR in group A was significantly decreased at T2,T3 and T4.Compared with group C,RR in group B was significantly decreased at T2,T3 and T4.The average range（the highest valuethe lowest value）of MAP,HR,BIS,and RR in group A was smaller than that in group B.Compared with group B,the onset time and recovery time of group A were shortened（bothP<0.05）.There was no significant difference in the number of drug additions and MOAA/S scores between the two groups.There was no significant difference in bradycardia,tachycardia,cough,body movement,hypoxemiaamong the three groups.There was no intraoperative hypotension events in the three groups.Compared with group C,the operation time of group B was significantly shortened,and the difference was statistically significant（P<0.05）.The frequency of hypertension in group A and group B was significantly lower than that in group C,and the difference was statistically significant（P<0.05）.The satisfaction of patients and operators in group A and group B was higher than that in group C,and the difference was statistically significant（P<0.05）.Conclusions Under the conditions of this clinical observation,when the elderly patients undergo fiberoptic bronchoscopy,we can use intravenous injection of remazolam tosylate 0.2 mg/kg,fentanyl 0.5 μg/kg for sedation,and additional anesthesia with fentanyl 25 μg if necessary.It has the advantages of rapid induction and recovery,high patient and operator satisfaction,and few adverse reactions,which has certain clinical application value.