右美托咪定鼻喷雾剂治疗颌面外科手术后第一晚睡眠障碍的临床观察:一项单中心双盲随机对照研究。

IF 2.9 4区 医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmacy and Pharmaceutical Sciences Pub Date : 2023-10-03 eCollection Date: 2023-01-01 DOI:10.3389/jpps.2023.11699
Ye Wang, Zibin Jin, Wenli Xu, Keyu Chen, Lingxin Wei, Dong Yang, Xiaoming Deng, Shiyi Tong
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引用次数: 0

摘要

目的:右美托咪定通过内源性促进睡眠途径并产生类似N2睡眠的状态来发挥镇静作用。本研究旨在研究右美托咪定鼻喷雾剂治疗术后睡眠障碍的疗效和安全性。方法:本研究招募了120名参与者[男性和女性;年龄,18-40岁;美国麻醉师协会一级或二级],他们在全麻下通过鼻气管插管接受了颌面外科手术。参与者被随机分为三组:空白对照组(BC组)、1.0μg/kg右美托咪定组(1.0Dex组)和1.5μg/kg右美托咪定小组(1.5Dex小组),每组40名患者。术后当晚21:30,干预组给予相应剂量的右美托咪定鼻喷雾剂。匹兹堡睡眠质量指数(PSQI)量表用于评估参与者术前1个月和术后当晚的基线睡眠状态。采用多导睡眠图(PSG)记录术后夜间睡眠情况。我们记录了术后第一晚镇静镇痛药物的抢救次数、不良反应、总住院时间和总费用。结果:与BC组患者相比,1.0Dex和1.5Dex组患者N2睡眠时间更长,给药后清醒时间更短,醒得次数更少,睡眠效率显著提高(p<0.05),与BC组和1.0Dex组相比,1.5Dex组患者N3睡眠时间显著延长,需要舒芬太尼抢救的频率降低,术后喉咙痛发生率降低,结论:1.0~1.5μg/kg右美托咪定雾化鼻喷雾剂能安全有效地改善颌面部手术后夜间的睡眠质量。值得注意的是,只有后者才能延长N3睡眠时间。证据水平II:至少从一项设计合理的随机对照试验中获得证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Clinical observation of dexmedetomidine nasal spray in the treatment of sleep disorders on the first night after undergoing maxillofacial surgery: a single-center double-blind randomized controlled study.

Purpose: Dexmedetomidine exerts a sedative effect by promoting the sleep pathway endogenously and producing a state similar to N2 sleep. This study aimed to study the efficacy and safety of dexmedetomidine nasal spray in the treatment of postoperative sleep disturbance. Methods: This study enrolled 120 participants [men and women; age, 18-40 years; American Society of Anesthesiologists grade, I or II] who underwent maxillofacial surgery under general anesthesia through nasotracheal intubation. The participants were randomly divided into three groups: blank control group (BC group), 1.0 μg/kg dexmedetomidine group (1.0 Dex group), and 1.5 μg/kg dexmedetomidine group (1.5 Dex group), with 40 patients allocated to each group. At 21:30 on the night after the operation, the intervention groups were administered their corresponding doses of dexmedetomidine nasal spray. The Pittsburgh Sleep Quality Index (PSQI) scale was used to evaluate the baseline sleep status of participants 1 month preoperatively and on the night after the operation. Polysomnography (PSG) was used to record the sleep status on the night after the operation. We recorded the rescue times of sedative and analgesic drugs on the first night after surgery, adverse reactions, total hospital stay duration, and total costs. Results: Compared with patients in the BC group, those in 1.0 Dex and 1.5 Dex groups had longer N2 sleep duration, were awake for a shorter time after dose administration, woke up less often, and had significantly improved sleep efficiency (p < 0.05). Compared with the BC group, the PSQI scores of 1.0 Dex and 1.5 Dex groups were significantly lower on the night after operation, and the proportion of PSQI > 5 was significantly lower (p < 0.05). Compared with patients in the BC group and the 1.0 Dex group, those in the 1.5 Dex group had significantly prolonged N3 sleep, reduced frequency of requiring sufentanil rescue, lower incidence of sore throat after surgery, and shorter average length of hospital stay (all, p < 0.05). Conclusion: The sleep quality of participants on the night after having undergone maxillofacial surgery was safely and effectively improved by 1.0-1.5 μg/kg dexmedetomidine atomized nasal sprays. Notably, only the latter could prolong N3 sleep. Level of Evidence II: Evidence was obtained from at least one properly designed randomized controlled trial.

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期刊介绍: The Journal of Pharmacy and Pharmaceutical Sciences (JPPS) is the official journal of the Canadian Society for Pharmaceutical Sciences. JPPS is a broad-spectrum, peer-reviewed, international pharmaceutical journal circulated electronically via the World Wide Web. Subscription to JPPS is free of charge. Articles will appear individually as soon as they are accepted and are ready for circulation.
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