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

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.

机构信息

Department of Anesthesiology, Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

出版信息

J Pharm Pharm Sci. 2023 Oct 3;26:11699. doi: 10.3389/jpps.2023.11699. eCollection 2023.

Abstract

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. 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. 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 ( < 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 ( < 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, < 0.05). 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. : Evidence was obtained from at least one properly designed randomized controlled trial.

摘要

右美托咪定通过促进内源性睡眠途径和产生类似于 N2 睡眠的状态发挥镇静作用。本研究旨在研究右美托咪定鼻喷剂治疗术后睡眠障碍的疗效和安全性。

该研究纳入了 120 名接受全身麻醉经鼻气管插管的颌面手术患者[男女;年龄 18-40 岁;美国麻醉医师协会分级 I 或 II 级]。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(1.0 Dex 组)和 1.5μg/kg 右美托咪定组(1.5 Dex 组),每组 40 例。术后当晚 21:30,干预组给予相应剂量的右美托咪定鼻喷剂。采用匹兹堡睡眠质量指数(PSQI)量表评估患者术前 1 个月和术后当晚的基线睡眠状况。多导睡眠图(PSG)记录术后当晚的睡眠状况。记录术后第 1 晚镇静和镇痛药物的解救次数、不良反应、总住院时间和总费用。

与 BC 组相比,1.0 Dex 组和 1.5 Dex 组患者的 N2 睡眠时间延长,给药后清醒时间缩短,醒来次数减少,睡眠效率显著提高(<0.05)。与 BC 组相比,1.0 Dex 组和 1.5 Dex 组患者术后当晚 PSQI 评分显著降低,PSQI>5 的比例显著降低(<0.05)。与 BC 组和 1.0 Dex 组相比,1.5 Dex 组患者的 N3 睡眠时间显著延长,舒芬太尼解救频率降低,术后咽痛发生率降低,平均住院时间缩短(均<0.05)。

1.0-1.5μg/kg 右美托咪定雾化鼻喷剂可安全有效地改善颌面手术后患者当晚的睡眠质量。值得注意的是,只有后者可以延长 N3 睡眠时间。

证据来源于至少一项设计合理的随机对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ac13/10579589/d06b1eae3582/jpps-26-11699-g001.jpg

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