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术前低剂量右美托咪定可降低老年髋部骨折患者脊髓麻醉术后谵妄的发生率:一项随机、双盲、对照临床研究。

Preoperative low-dose dexmedetomidine reduces postoperative delirium in elderly patients with hip fracture under spinal anesthesia: A randomized, double blind, controlled clinical study.

作者信息

Geng Pengcheng, Shang Zixiang, Cheng Feng, Zhang Yujie, Deng Xin, Chen Xia, Zhan Li, Zheng Lidong, Liu Xuesheng

机构信息

Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China; Department of Anesthesiology, Lu'an Hospital of Anhui Medical University, Lu'an, Anhui, China.

Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.

出版信息

J Clin Anesth. 2025 Jul;105:111897. doi: 10.1016/j.jclinane.2025.111897. Epub 2025 Jun 12.

DOI:10.1016/j.jclinane.2025.111897
PMID:40513143
Abstract

STUDY OBJECTIVE

This study aims to evaluate the effects of preoperative low-dose dexmedetomidine administration for one night on the incidence of postoperative delirium in elderly patients with hip fracture.

DESIGN

This was a randomized, double blind, placebo-controlled clinical trial.

SETTING

Lu'an Hospital of Anhui Medical University, Anhui, China.

PATIENTS

Patients aged ≥65 years with hip fracture (femoral neck, intertrochanteric, or subtrochanteric fracture) and scheduled for surgical repair(total hip arthroplasty, hemiarthroplasty, internal fixation with cannulated screw or intramedullary nail) under spinal anesthesia were eligible.

INTERVENTION

Patients were randomized 1:1 to receive low-dose dexmedetomidine or placebo from 8:00 pm before surgery to 8:00 am the day of surgery.

MEASUREMENTS

The primary outcome was the incidence of POD between postoperative days 1 and 7 or at hospital discharge. The secondary outcome measures included preoperative sleep quality, days of delirium, visual analog scale scores in quiet and active states on postoperative days 1-3, C-reactive protein level, number of analgesic pump presses, activities of daily living score at discharge and postoperative hospital stay. Perioperative adverse events were recorded.

MAIN RESULTS

Of the 248 patients randomized to the placebo (n = 124) or dexmedetomidine (n = 124) group, 233 participants (117 in the placebo group and 116 in the dexmedetomidine group) were included in the modified intention-to-treat analysis. The incidence of POD was lower in the dexmedetomidine group (10.3 %) than placebo group (22.2 %, P = 0.014). Compared to the placebo group, the dexmedetomidine group had higher preoperative Leeds Sleep Evaluation Questionnaire (LSEQ) scores (P < 0.001), lower preoperative Insomnia Severity Index (ISI) scores (P < 0.001), and lower postoperative C-reactive protein (CRP) levels (P < 0.001). No differences in other secondary outcomes and perioperative adverse events were observed between the two groups.

CONCLUSION

In patients aged ≥65 years undergoing elective hip fracture surgery under spinal anesthesia, continuous overnight administration of low-dose dexmedetomidine improved sleep quality on the night before surgery and reduced the incidence of POD.

摘要

研究目的

本研究旨在评估术前一晚给予低剂量右美托咪定对老年髋部骨折患者术后谵妄发生率的影响。

设计

这是一项随机、双盲、安慰剂对照临床试验。

地点

中国安徽安徽医科大学附属六安医院。

患者

年龄≥65岁、患有髋部骨折(股骨颈、转子间或转子下骨折)且计划在脊髓麻醉下行手术修复(全髋关节置换术、半髋关节置换术、空心螺钉内固定或髓内钉内固定)的患者符合条件。

干预措施

患者按1:1随机分组,从手术前晚8:00至手术当天上午8:00接受低剂量右美托咪定或安慰剂。

测量指标

主要结局是术后1至7天或出院时的术后谵妄发生率。次要结局指标包括术前睡眠质量、谵妄天数、术后1至3天安静和活动状态下的视觉模拟量表评分、C反应蛋白水平、镇痛泵按压次数、出院时日常生活活动评分和术后住院时间。记录围手术期不良事件。

主要结果

在随机分为安慰剂组(n = 124)或右美托咪定组(n = 124)的248例患者中,233例参与者(安慰剂组117例,右美托咪定组116例)纳入改良意向性分析。右美托咪定组的术后谵妄发生率(10.3%)低于安慰剂组(22.2%,P = 0.014)。与安慰剂组相比,右美托咪定组术前利兹睡眠评估问卷(LSEQ)评分更高(P < 0.001),术前失眠严重程度指数(ISI)评分更低(P < 0.001),术后C反应蛋白(CRP)水平更低(P < 0.001)。两组在其他次要结局和围手术期不良事件方面未观察到差异。

结论

在年龄≥65岁、接受脊髓麻醉下择期髋部骨折手术的患者中,术前一晚持续给予低剂量右美托咪定可改善手术前一晚的睡眠质量,并降低术后谵妄的发生率。

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