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确定艾司氯胺酮联合丙泊酚用于无痛宫腔镜检查的有效剂量:一项前瞻性剂量探索研究。

Determining the effective dose of esketamine combined with propofol for painless hysteroscopy: a prospective dose-finding study.

作者信息

Sheng Zhimin, Liu Xiang, Lin Kang, Liu Jie, Mao Junqin, Qian Xiaowei

机构信息

Department of Anesthesiology, Wenling Maternity and Child Healthcare Hospital, Taizhou, China.

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

出版信息

Front Pharmacol. 2024 Dec 16;15:1419732. doi: 10.3389/fphar.2024.1419732. eCollection 2024.

Abstract

BACKGROUND

The combination of esketamine and propofol has become a common choice for total intravenous anesthesia in hysteroscopic procedures. However, the optimal effective dose has not yet been determined. The aim of this study was to determine the median effective dose (ED) and 95% effective dose (ED) of esketamine compounded with propofol for painless hysteroscopy.

METHODS

A total of 40 patients aged 20-60 years and scheduled for painless hysteroscopy under intravenous anesthesia were recruited, and a total of 31 patients were enrolled for the final analysis. Using the Dixon's up and down method, an initial dose of 0.5 mg/kg esketamine was administered intravenously before surgery, and after 1 min, it was followed by 2 mg/kg of propofol. If the hysteroscopy failed (a positive reaction) [defined as inadequate cervical dilatation, patient body movements interfering with surgical procedures during hysteroscopy placement, frowning, or Ramsay Sedation Scale (RSS) score <5 within 5 min], the subsequent patient's esketamine dosage was increased by 0.1 mg/kg. Conversely (a negative reaction), the dosage was decreased by 0.1 mg/kg. The test was not stopped until at least 7 crossovers occurred. The perioperative adverse events of each patient were recorded. The ED and ED with 95% confidence intervals (CIs) were estimated using probit regression.

RESULTS

The ED and ED with 95% (CIs) of esketamine in patients were 0.287 (0.220-0.342) mg/kg and 0.429 (0.365-0.705) mg/kg, respectively. No serious adverse events were observed in any patients.

CONCLUSION

A dose of 0.429 mg/kg esketamine combined with propofol is recommended for painless hysteroscopy anesthesia, as it enhances anesthesia and postoperative analgesia efficacy without significant adverse reactions. However, potential risks associated with this dosage should be carefully considered in clinical practice.

CLINICAL TRIAL REGISTRATION

https://www.chictr.org.cn/index.html, identifier ChiCTR2300075564.

摘要

背景

艾司氯胺酮与丙泊酚联合使用已成为宫腔镜手术全静脉麻醉的常见选择。然而,最佳有效剂量尚未确定。本研究的目的是确定艾司氯胺酮复合丙泊酚用于无痛宫腔镜检查的半数有效剂量(ED)和95%有效剂量(ED)。

方法

共招募40例年龄在20至60岁之间、计划在静脉麻醉下进行无痛宫腔镜检查的患者,最终纳入31例患者进行分析。采用序贯法,术前静脉注射初始剂量0.5mg/kg艾司氯胺酮,1分钟后静脉注射2mg/kg丙泊酚。如果宫腔镜检查失败(阳性反应)[定义为宫颈扩张不足、宫腔镜置入过程中患者身体移动干扰手术操作、皱眉或5分钟内 Ramsay 镇静评分(RSS)<5],则随后患者的艾司氯胺酮剂量增加0.1mg/kg。反之(阴性反应),剂量减少0.1mg/kg。直到至少发生7次交叉后试验才停止。记录每位患者的围手术期不良事件。采用概率回归估计ED和95%置信区间(CI)对应的ED。

结果

患者艾司氯胺酮的ED及95%(CI)分别为0.287(0.220 - 0.342)mg/kg和0.429(0.365 - 0.705)mg/kg。未观察到任何患者发生严重不良事件。

结论

推荐0.429mg/kg艾司氯胺酮联合丙泊酚用于无痛宫腔镜麻醉,因为它可增强麻醉和术后镇痛效果且无明显不良反应。然而,临床实践中应仔细考虑该剂量相关的潜在风险。

临床试验注册

https://www.chictr.org.cn/index.html,标识符ChiCTR2300075564。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e995/11683100/8cf7dffb9bb1/fphar-15-1419732-g001.jpg

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