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瑞马唑仑与丙泊酚对结肠镜检查深度镇静患者呼吸影响的比较:一项前瞻性多中心随机对照试验

Comparison of effect of remimazolam and propofol on respiration of patients under deep sedation for colonoscopy: a prospective multicenter randomized controlled trial.

作者信息

Wang Zhengjia, Zhan Renshu, Mo Liqun, Zhang Jin, Hu Jie, Tan Shoupeng, He Qiongzhen, Li Ping, Sun Wekong, Wang Xiaobin, Jiang Jun, Liu Li, Zhang Yingying, Bai Yiping

机构信息

Department of Anesthesiology, The Affiliated Hospital, Southwest Medical University, 25 Taiping Street, Luzhou, 646000, China.

Anesthesiology and Critical Care Medicine Key Laboratory of Luzhou, Luzhou, China.

出版信息

Eur J Med Res. 2025 Apr 7;30(1):250. doi: 10.1186/s40001-025-02519-1.

DOI:10.1186/s40001-025-02519-1
PMID:40189570
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11974117/
Abstract

BACKGROUND

Remimazolam recently became available as a sedative. The comparison of the respiratory suppression effects of remimazolam and propofol under deep sedation for colonoscopy was not thoroughly unclear, particularly with regard to the novel metric of time to first airway intervention. The goal of this study was to systemically compare the respiration profiles of the patients sedated with remimazolam and propofol at the comparable sedation level in the patients undergoing colonoscopy.

METHODS

Four hundred-fifty outpatients were randomly assigned to remimazolam (Group Rem, n = 225) and propofol (Group Pro, n = 225). The target sedation level was the modified Observer's Assessment of Alertness/Sedation ≤ 2. The primary outcome was elapsed time from anesthesia induction to first airway intervention. Secondary outcomes included incidence and severity of hypoxia and apnea, minute ventilation (MV), tidal volume (TV), and respiratory rate (RR).

RESULTS

The elapsed time from induction to the first airway intervention was 11 ± 8 min in Group Rem (n = 208) vs. 5 ± 6 min in Group Pro (n = 208, P < 0.001). Patients in Group Rem required less frequent airway intervention and had a lower incidence of and shorter duration of apnea than patients in Group Pro (all P < 0.001). MV at 1 min, 2 min, 4 min post-induction, and at the end of the procedure were higher in Group Rem than those in Group Pro (P < 0.001).

CONCLUSIONS

Patients sedated with remimazolam vs. propofol during colonoscopy maintain improved respiration and require less frequent airway intervention, and have lower incidence of adverse events. Clinical trial registration and registry URL ChiCTR2000034527, registered at www.chictr.org.cn.

摘要

背景

瑞马唑仑最近作为一种镇静剂上市。在结肠镜检查深度镇静下,瑞马唑仑和丙泊酚对呼吸抑制作用的比较尚不完全清楚,特别是在首次气道干预时间这一新指标方面。本研究的目的是系统比较结肠镜检查患者在可比镇静水平下接受瑞马唑仑和丙泊酚镇静时的呼吸情况。

方法

450例门诊患者被随机分为瑞马唑仑组(瑞组,n = 225)和丙泊酚组(丙组,n = 225)。目标镇静水平为改良的观察者警觉/镇静评分≤2分。主要结局是从麻醉诱导到首次气道干预的时间。次要结局包括低氧血症和呼吸暂停的发生率及严重程度、分钟通气量(MV)、潮气量(TV)和呼吸频率(RR)。

结果

瑞组(n = 208)从诱导到首次气道干预的时间为11±8分钟,丙组(n = 208)为5±6分钟(P < 0.001)。与丙组患者相比,瑞组患者气道干预频率更低,呼吸暂停发生率更低且持续时间更短(均P < 0.001)。诱导后1分钟、2分钟、4分钟及手术结束时,瑞组的MV高于丙组(P < 0.001)。

结论

结肠镜检查期间,与丙泊酚镇静的患者相比,瑞马唑仑镇静的患者呼吸状况更好,气道干预频率更低,不良事件发生率更低。临床试验注册及注册网址ChiCTR2000034527,在www.chictr.org.cn注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33f6/11974117/47333ac7ad2c/40001_2025_2519_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33f6/11974117/0b7e9b03b935/40001_2025_2519_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33f6/11974117/47333ac7ad2c/40001_2025_2519_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33f6/11974117/0b7e9b03b935/40001_2025_2519_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/33f6/11974117/47333ac7ad2c/40001_2025_2519_Fig2_HTML.jpg

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