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瑞马唑仑对老年全膝关节置换术后睡眠质量的影响:一项随机对照试验。

Effect of intraoperative remimazolam on postoperative sleep quality in elderly patients after total joint arthroplasty: a randomized control trial.

机构信息

Department of Anesthesiology, Peking University First Hospital, No. 8 Xishiku Street, Beijing, 100034, China.

Department of Anesthesiology, Cangzhou People's Hospital, Cangzhou, Hebei, China.

出版信息

J Anesth. 2023 Aug;37(4):511-521. doi: 10.1007/s00540-023-03193-5. Epub 2023 Apr 13.

DOI:10.1007/s00540-023-03193-5
PMID:37055671
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10390348/
Abstract

PURPOSE

To investigate the effect of intraoperative remimazolam sedation on postoperative sleep quality in elderly patients after total joint arthroplasty.

METHODS

Between May 15, 2021 and March 26, 2022, 108 elderly patients (age ≥ 65 years) who received total joint arthroplasty under neuraxial anesthesia were randomized into remimazolam group (a loading dose of 0.025-0.1 mg/kg and followed by an infusion rate of 0.1-1.0 mg/kg/h till end of surgery) or routine group (sedation was given on patient's requirement by dexmedetomidine 0.2-0.7 μg/kg/h). Primary outcome was the subjective sleep quality at surgery night which was evaluated by Richards Campbell Sleep Questionnaire (RCSQ). Secondary outcomes included RCSQ scores at postoperative first and second nights and numeric rating scale pain intensity within first 3 days after surgery.

RESULTS

RCSQ score at surgery night was 59 (28, 75) in remimazolam group which was comparable with 53 (28, 67) in routine group (median difference 6, 95% CI - 6 to 16, P = 0.315). After adjustment of confounders, preoperative high Pittsburg sleep quality index was associated worse RCSQ score (P = 0.032), but not remimazolam (P = 0.754). RCSQ score at postoperative first night [69 (56, 85) vs. 70 (54, 80), P = 0.472] and second night [80 (68, 87) vs. 76 (64, 84), P = 0.066] were equivalent between two groups. Safety outcomes were comparable between the two groups.

CONCLUSIONS

Intraoperative remimazolam did not significantly improve postoperative sleep quality in elderly patients undergoing total joint arthroplasty. But it is proved to be effective and safe for moderate sedation in these patients.

CLINICAL TRIAL NUMBER AND REGISTRY URL

ChiCTR2000041286 ( www.chictr.org.cn ).

摘要

目的

研究术中 remimazolam 镇静对老年全关节置换术后睡眠质量的影响。

方法

2021 年 5 月 15 日至 2022 年 3 月 26 日,108 例年龄≥65 岁的接受椎管内麻醉下全关节置换术的老年患者随机分为 remimazolam 组(负荷剂量 0.025-0.1mg/kg,随后输注速率 0.1-1.0mg/kg/h 直至手术结束)或常规组(根据患者需要给予右美托咪定 0.2-0.7μg/kg/h 镇静)。主要结局为手术当晚的主观睡眠质量,采用 Richards Campbell 睡眠问卷(RCSQ)评估。次要结局包括术后第 1 天和第 2 天的 RCSQ 评分和术后第 1-3 天的数字评分量表疼痛强度。

结果

remimazolam 组手术当晚的 RCSQ 评分为 59(28,75),与常规组的 53(28,67)相当(中位数差值 6,95%CI-6 至 16,P=0.315)。在调整混杂因素后,术前高匹兹堡睡眠质量指数与较差的 RCSQ 评分相关(P=0.032),但与 remimazolam 无关(P=0.754)。两组术后第 1 天[69(56,85)比 70(54,80),P=0.472]和第 2 天[80(68,87)比 76(64,84),P=0.066]的 RCSQ 评分相当。两组的安全性结局相当。

结论

术中 remimazolam 并未显著改善老年全关节置换术后的睡眠质量。但它被证明对这些患者的中度镇静是有效和安全的。

临床试验编号和注册网址

ChiCTR2000041286(www.chictr.org.cn)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b815/10390348/d692eda85148/540_2023_3193_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b815/10390348/4900c42e6e90/540_2023_3193_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b815/10390348/d692eda85148/540_2023_3193_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b815/10390348/4900c42e6e90/540_2023_3193_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b815/10390348/d692eda85148/540_2023_3193_Fig2_HTML.jpg

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