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瑞马唑仑联合丙泊酚用于日间宫腔镜手术静脉镇静时半数有效剂量和 95%有效剂量的测定。

Determination of the 50% and 95% Effective Dose of Remimazolam Combined with Propofol for Intravenous Sedation During Day-Surgery Hysteroscopy.

机构信息

Department of Anesthesiology, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China.

出版信息

Drug Des Devel Ther. 2023 Jun 13;17:1753-1761. doi: 10.2147/DDDT.S406514. eCollection 2023.

Abstract

PURPOSE

Remimazolam has demonstrated the potential as a valuable medication for procedural sedation. However, there were some shortcomings for higher doses of remimazolam during hysteroscopy in spite of less frequent adverse events. The aim of this study was to find the 50% and 95% effective dose (ED and ED) of remimazolam when combined with propofol for intravenous sedation during day-surgery hysteroscopy.

PATIENTS AND METHODS

Patients were randomly assigned evenly (20 per group) to one of five different dosage of remimazolam: group A (0.05mg/kg), group B (0.075mg/kg), group C (0.1mg/kg), group D (0.125mg/kg) or group E (0.15mg/kg). Intravenous injection of sufentanil 0.1µg/kg was administered before sedative medication. Intravenous anesthesia was commenced with remimazolam. Subsequently, propofol was administered at 1mg/kg and maintained at 6mg/kg/h. Success was defined when the patient did not move during cervical dilation, had sufficient sedation as judged by SE <60 and no requirement for rescue doses. The success rate, induce and average dosage of propofol, the induction time, total surgery time, recovery time, and adverse events were recorded. Estimate of ED and ED with 95% confidence interval (CI) was performed by probit regression.

RESULTS

The mean (95% CI) values for ED and ED of remimazolam in patients were 0.09 (0.08-0.11) mg/kg and 0.21 (0.16-0.35) mg/kg, respectively. There was no difference in the induction time, total surgery time, and recovery time among groups. No serious adverse events occurred in all patients.

CONCLUSION

The dose-response effects of remimazolam were evaluated for intravenous sedation during hysteroscopy. A combination of remimazolam and propofol was recommended to produce stabler sedation, reduce the total dosage and have less effect on cardiovascular and respiratory depression.

摘要

目的

咪达唑仑在镇静治疗方面具有很大的潜力。但是,尽管不良事件发生频率较低,在宫腔镜检查中给予更高剂量的咪达唑仑仍存在一些缺点。本研究旨在寻找咪达唑仑联合丙泊酚用于日间宫腔镜手术静脉镇静时的 50%和 95%有效剂量(ED 和 ED)。

患者和方法

患者被平均随机分配(每组 20 例)至五个不同咪达唑仑剂量组之一:A 组(0.05mg/kg)、B 组(0.075mg/kg)、C 组(0.1mg/kg)、D 组(0.125mg/kg)或 E 组(0.15mg/kg)。在镇静药物给药前给予舒芬太尼 0.1µg/kg 静脉注射。静脉麻醉开始给予咪达唑仑,随后给予丙泊酚 1mg/kg,并维持 6mg/kg/h。当患者在宫颈扩张期间不移动、镇静评分(SE)<60 且无需抢救剂量时,定义为成功。记录成功率、丙泊酚的诱导和平均剂量、诱导时间、总手术时间、恢复时间和不良事件。通过概率回归估计 ED 和 ED 的 95%置信区间(CI)。

结果

患者中咪达唑仑的 ED 和 ED 的平均值(95%CI)分别为 0.09(0.08-0.11)mg/kg 和 0.21(0.16-0.35)mg/kg。各组之间的诱导时间、总手术时间和恢复时间无差异。所有患者均未发生严重不良事件。

结论

评估了咪达唑仑在宫腔镜检查期间静脉镇静的剂量反应效应。推荐咪达唑仑与丙泊酚联合使用,以产生更稳定的镇静作用,减少总剂量,并对心血管和呼吸抑制的影响更小。

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