瑞马唑仑复合瑞芬太尼在无痛胃镜检查中的临床应用

Clinical application of remimazolam combined with remifentanil in painless gastroscopy

目的探讨瑞马唑仑复合瑞芬太尼在无痛胃镜检查中的最佳使用剂量。方法本研究为随机、单盲对照研究。行无痛胃镜检查的患者699例,按随机数字表法分为7组:A组(0.2 mg/kg瑞马唑仑复合0.25μg/kg瑞芬太尼,100例)、B组(0.3 mg/kg瑞马唑仑复合0.25μg/kg瑞芬太尼,100例)、C组(0.4 mg/kg瑞马唑仑复合0.25μg/kg瑞芬太尼,100例)、D组(0.2 mg/kg瑞马唑仑复合0.50μg/kg瑞芬太尼,100例)、E组(0.3 mg/kg瑞马唑仑复合0.50μg/kg瑞芬太尼,100例)、F组(0.4 mg/kg瑞马唑仑复合0.50μg/kg瑞芬太尼,100例)、R组(2 mg/kg丙泊酚,99例)。记录7组患者入室后(T_(0))、给药结束后1 min(T_(1))、胃镜操作时第1分钟(T_(2))、胃镜操作时第3分钟(T_(3))、胃镜操作时第5分钟(T_(4))、离院时(T_(5))的心率、MAP,记录7组患者胃镜检查操作时间、苏醒时间、离院时间、并发症(呼吸抑制、低氧血症、低血压、呛咳、呃逆、体动等)发生情况、镇静成功率、患者满意度评分及操作者满意度评分。记录瑞芬太尼0.25μg/kg的3组、瑞芬太尼0.50μg/kg的3组、瑞马唑仑0.2 mg/kg的2组、瑞马唑仑0.3 mg/kg的2组、瑞马唑仑0.4 mg/kg的2组呃逆的发生率,分析两种药物剂量与呃逆的相关性。结果A、B、C、D、E、F组的镇静成功率高于R组(P<0.05)。当瑞芬太尼剂量恒定时、增加瑞马唑仑的剂量,或者当瑞马唑仑剂量恒定时、增加瑞芬太尼的剂量,镇静成功率都随之增加(P<0.05),胃镜检查过程中心率和MAP波动减小、呛咳及体动发生率降低、患者及操作者满意度评分增高(P<0.05);但同时,呼吸抑制及低血压的发生率也随之升高、心率和MAP下降幅度增大、患者苏醒时间与离院时间也逐渐延长(P<0.05)。瑞马唑仑剂量与呃逆的发生间呈弱正相关(0.25μg/kg,r=0.180,P<0.05;0.50μg/kg,r=0.272,P<0.05),瑞芬太尼剂量与呃逆的发生间呈负相关(0.2 mg/kg,r=−0.400,P<0.05;0.30 mg/kg,r=−0.386,P<0.05;0.40 mg/kg,r=−0.303,P<0.05)。结论瑞马唑仑复合瑞芬太尼可安全用于无痛检查,0.3 mg/kg瑞马唑仑复合0.25μg/kg瑞芬太尼剂量更为合适。

Objective To explore the optimal dose of remimazolam combined with remifentanil in painless gastroscopy.Methods It was a randomized,single⁃blind,controlled study.A total of 699 patients who underwent painless gastroscopy,According to the random number table method,they were divided into seven groups.Groups A(n=100),B(n=100),and C(n=100)were treated with 0.2 mg/kg,0.3 mg/kg or 0.4 mg/kg of remimazolam combined with 0.25μg/kg of remifentanil,respectively.Groups D(n=100),E(n=100)and F(n=100)were treated with 0.2 mg/kg,0.3 mg/kg and 0.4 mg/kg of remifentanil combined with 0.50μg/kg of remifent⁃anil.Group R(n=99)was administered with 2 mg/kg of propofol.Their sedation success rate,circulatory and respiratory system indica⁃tors,incidence of adverse reactions,recovery time and quality,andsatisfaction of patients and operating doctors were compared.We re⁃corded the incidence of hiccups between 3 groups of remifentanil 0.25μg/kg,3 groups of remifentanil 0.50μg/kg,2 groups of remima⁃zolam 0.2 mg/kg,2 groups of remimazolam 0.3 mg/kg,2 groups of remimazolam 0.4 mg/kg and analyzed the correlation between two drug doses and hiccups.Results The sedation success rate of group A,B,C,D,E,F was higher than that of group R(P<0.05).The success rate of sedation increasing shows dose dependence of remimazolam when the dose of remifentanil is constant,or dose dependency of remifentanil when the dose of remimazolam is constant.The heart rate and mean arterial pressure(MAP)fluctuations of patients during gastroscopy were reduced with the increased sedation rate.Also,with the increased sedation rate,the volatility and the inci⁃dence of coughing and body movement decreased while the satisfaction scores of patients and operators increased(P<0.05).However,with the increased sedation extent,the incidence of respiratory depression and hypotension were also increased while the amplitude of heart rate decreasing and MAP increased.The patient's time to wake up and leave the hospital were prolonged(P<0.05).There was a significant weak positive correlation between the dose of remimazolam and the occurrence of hiccups(0.25μg/kg,r=0.180,P<0.05;0.50μg/kg,r=0.272,P<0.05),while a significant negative correlation between the dose of remifentanil and the occurrence of hiccups(0.2 mg/kg,r=−0.400,P<0.05;0.30 mg/kg,r=−0.386,P<0.05;0.40 mg/kg,r=−0.303,P<0.05).Conclusions The combined use of remimazolam and remifentanil is safe during painless examination,and 0.3 mg/kg of remimazolam combined with 0.25μg/kg of remi⁃fentanil is an appropriate dose combination.