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瑞马唑仑复合瑞芬太尼用于无肌松药下引导气管插管的半数有效剂量:上下序贯法分配试验。

Effective dose of remimazolam co-administered with remifentanil to facilitate I-gel insertion without neuromuscular blocking agents: an up-and-down sequential allocation trial.

机构信息

Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164 Worldcup-Ro, Yeongtong-Gu, Suwon, 16499, Republic of Korea.

Office of Biostatics, Medical Research Collaborating Center, Ajou Research Institute for Innovative Medicine, Ajou University Medical Center, Suwon, Republic of Korea.

出版信息

BMC Anesthesiol. 2023 Mar 16;23(1):81. doi: 10.1186/s12871-023-02041-z.

DOI:10.1186/s12871-023-02041-z
PMID:36927413
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10018909/
Abstract

BACKGROUND

Remimazolam is a new anesthetic drug developed and is an ultra-short-acting agent with rapid onset and offset. The pharmacology of this drug seems to be ideal for short surgeries eligible for I-gel insertion. Therefore, this study aimed to determine the optimal bolus dose of remimazolam for I-gel insertion when co-administered with remifentanil without neuromuscular blocking agents (NMBAs).

METHODS

Patients aged 19-65 years with American Society of Anesthesiologists physical status I or II scheduled for general anesthesia were enrolled. The first dose of remimazolam was 0.15 mg/kg and remifentanil was co-administered at an effect-site concentration (Ce) of 3.0 ng/mL. The dose of remimazolam for the following patient was decreased or increased by 0.05 mg/kg depending on the success or failure of I-gel insertion in the previous patient.

RESULTS

The remimazolam bolus dose required for successful I-gel insertion in 50% of adult patients using modified Dixon's up-and-down method with remifentanil Ce 3.0 ng/mL and no NMBAs was 0.280 ± 0.048 mg/kg. Isotonic regression analysis showed that the 50% and 95% effective doses were 0.244 (83% confidence interval [CI] 0.213-0.313) mg/kg and 0.444 (95% CI 0.436-0.448) mg/kg, respectively. The mean time to loss of consciousness (Modified Observer's Assessment of Alertness/Sedation score < 2) was 52.2 s. Three patients (12.0%) showed a reduction in systolic blood pressure of more than 30% from baseline.

CONCLUSIONS

Selecting the appropriate dose of remimazolam/remifentanil without NMBAs makes it feasible to insert the I-gel.

TRIAL REGISTRATION

This study protocol was registered at http://cris.nih.go.kr (KCT0007801, 12th, October, 2022).

摘要

背景

雷米唑仑是一种新的麻醉药物,具有起效迅速、消除迅速的特点。这种药物的药理学似乎非常适合适合插入 I-gel 的短手术。因此,本研究旨在确定在没有神经肌肉阻滞剂 (NMBAs) 的情况下,与瑞芬太尼联合使用时,雷米唑仑用于 I-gel 插入的最佳推注剂量。

方法

纳入年龄在 19-65 岁之间、ASA 身体状况 I 或 II 级、拟行全身麻醉的患者。首剂量为 0.15mg/kg 雷米唑仑,同时给予瑞芬太尼效应部位浓度 (Ce) 为 3.0ng/mL。根据前一位患者 I-gel 插入的成功或失败,下一位患者的雷米唑仑剂量减少或增加 0.05mg/kg。

结果

采用改良 Dixon 上下法,使用雷米唑仑 Ce 3.0ng/mL 和无 NMBAs 时,50%成人患者成功插入 I-gel 所需的雷米唑仑推注剂量为 0.280±0.048mg/kg。等张回归分析显示,50%和 95%有效剂量分别为 0.244(83%可信区间 [CI] 0.213-0.313)mg/kg 和 0.444(95% CI 0.436-0.448)mg/kg。意识丧失(改良观察者评估警觉/镇静评分<2)的平均时间为 52.2s。3 名患者(12.0%)的收缩压从基线下降超过 30%。

结论

选择合适的雷米唑仑/瑞芬太尼剂量(无 NMBAs)可使 I-gel 插入变得可行。

试验注册

本研究方案在 http://cris.nih.go.kr 注册(KCT0007801,2022 年 10 月 12 日)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/6712e5bee792/12871_2023_2041_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/9a307fb605e2/12871_2023_2041_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/40fe172fdec6/12871_2023_2041_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/574d32b1657b/12871_2023_2041_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/6712e5bee792/12871_2023_2041_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/9a307fb605e2/12871_2023_2041_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/40fe172fdec6/12871_2023_2041_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/574d32b1657b/12871_2023_2041_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/20e6/10018909/6712e5bee792/12871_2023_2041_Fig4_HTML.jpg

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