Abstract:

Objective　To explore the sedation effect of remimazolam tosilate for injection in painless gastroenteroscopy. Methods　Four hundred and eight patients undergoing painless gastroenteroscopy in Yanggu County People's Hospital from December 2022 to January 2024 were selected for the randomized controlled trial, with 204 cases in each group. They were divided into a remimazolam tosilate for injection group (group R) and a propofol group (group P) by the random number table method, with 204 cases in each group. There were 113 males and 91 females in group R; they were (37.68±5.33) years old; their body mass index was (22.41±1.57) kg/m²; there were 127 cases of grade Ⅰ and 77 cases of grade Ⅱ of American Society of Anesthesiologists grading. There were 127 males and 77 females in group P; they were (38.09±5.76) years old; their body mass index was (22.56±1.74) kg/m²; there were 130 cases of grade Ⅰ and 74 cases of grade Ⅱ of ASA grading. The success rates, induction times and recovery times of sedation, incidences of hypotension, treated hypotension, and respiratory depression, and hemodynamic parameters [diastolic blood pressure (DBP), systolic blood pressure (SBP), heart rate (HR), blood oxygen saturation (SpO₂), respiratory rate (RR)] at different time points (before the induction and 1, 3, 6, 9, 12, 15, and 20 min after the induction) were compared between the two groups. The satisfaction and adverse reactions were recorded. The analysis of repeated measurement variance, t test, and χ² test were used. Results　The success rates of sedation in the two groups both were 100.00% (204/204). The induction time and recovery time of sedation in group R were shorter than those in group P [(34.19±4.52) s vs. (40.52±5.06) s and (5.72±1.07) min vs. (7.33±1.28) min; t=13.325 and 13.784; both P<0.05]. The incidences of hypotension, treated hypotension, and respiratory depression in group R were lower than those in group P [10.29% (21/204) 22.55% vs. (46/204), 2.94% (6/204) vs. 8.82% (18/204), and 5.39% (11/204) vs. 11.27% (23/204); χ²=11.161, 6.375, and 4.620; all P<0.05]. One, 3, 6, 9, and 12 min after the induction, the SBP, DBP, HR, RR, and SpO₂ decreased first and then increased in both groups, and there were statistical differences between the two groups (all P<0.05). The scores of satisfaction of the patients, anesthesiologists, and endoscopists in group R were higher than those in group P [(8.24±0.76) vs. (6.37±1.16), (8.08±0.82) vs. (6.53±1.37), (8.59±0.60) vs. (7.12±1.24); t=19.259, 13.866, and 15.242; all P<0.05]. The incidence of hypoxemia and total incidence of adverse reactions in group R were lower than those in group P [7.35% (15/204) vs. 18.14% (37/204) and 20.10% (41/204) vs. 31.37%(64/204); χ²=10.667 and 6.784; both P<0.05]. Conclusions　Sedation effect of remimazolam tosilate for injection is significant in painless gastroenteroscopy. It can maintain hemodynamics stability, shorten recovery time, reduce the incidence of adverse reactions (hypotension and hypoxemia), and improve satisfaction.

Key words:

Sedation, Remimazolam tosilate for injection, Painless gastroenteroscopy, Adverse reactions

摘要：

目的　探讨注射用甲苯磺酸瑞马唑仑用于无痛胃肠镜诊疗中的镇静效果。方法　选取2022年12月至2024年1月在阳谷县人民医院接受无痛胃肠镜检查的408例患者进行随机对照试验。采用随机数字表法将其分为注射用甲苯磺酸瑞马唑仑组（R组）和丙泊酚组（P组），各204例。R组男113例，91例，年龄（37.68±5.33）岁，体质量指数（22.41±1.57）kg/m²，美国麻醉医师协会（American Society of Anesthesiologists，ASA）分级Ⅰ级127例，Ⅱ级77例。P组男127例，女77例，年龄（38.09±5.76）岁，体质量指数（22.56±1.74）kg/m²，ASA分级Ⅰ级130例，Ⅱ级74例。比较两组镇静成功率、镇静诱导时间、镇静苏醒时间、低血压发生率、需治疗的低血压发生率、呼吸抑制发生率及不同时间点（诱导前和诱导后1 min、3 min、6 min、9 min、12 min、15 min、20 min）血流动力学参数［舒张压（diastolic blood pressure，DBP）、收缩压（systolic blood pressure，SBP）、心率（heart rate，HR）、血氧饱和度（SpO₂）、呼吸频率（respiratory rate，RR）］，并记录两组满意度及不良反应。采用重复测量方差分析、t检验和χ²检验。结果　两组镇静成功率均为100.00%（204/204）。R组镇静诱导时间、镇静苏醒时间均短于P组［（34.19±4.52）s比（40.52±5.06）s、（5.72±1.07）min比（7.33±1.28）min；t=13.325、13.784，均P<0.05］。R组低血压、需治疗的低血压、呼吸抑制发生率均低于P组［10.29%（21/204）比22.55%（46/204）、2.94%（6/204）比8.82%（18/204）、5.39%（11/204）比11.27%（23/204）；χ²=11.161、6.375、4.620、均P <0.05］。两组诱导后1 min、3 min、6 min、9 min、12 min SBP、DBP、HR、RR、SpO₂均呈先下降后上升趋势，且两组比较，差异均有统计学意义（均P<0.05）。R组患者满意度评分为（8.24±0.76）分，麻醉医生及内镜医生对R组的满意度评分为（8.08±0.82）分、（8.59±0.60）分，均高于P组的（6.37±1.16）分、（6.53±1.37）分、（7.12±1.24）分（t=19.259、13.866、15.242，均P<0.05）。R组低氧血症及总不良反应发生率分别为7.35%（15/204）、20.10%（41/204），均低于P组的18.14%（37/204）、31.37%（64/204）（χ²=10.667、6.784，均P<0.05）。结论　注射用甲苯磺酸瑞马唑仑在无痛胃肠镜的诊疗中应用具有镇静效应，可维持患者血流动力学稳定，缩短患者苏醒时间，降低低血压、低氧血症等不良反应发生率，并提高满意度。

关键词:

镇静, 注射用甲苯磺酸瑞马唑仑, 无痛胃肠镜, 不良反应