Yang Xiu, Hu Jing-Hui, Fan Li-Ping, Peng Hui-Ping, Shi Hai-Jing, Zhuang Min-Yuan, Ji Fu-Hai, Peng Ke
Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Institute of Anesthesiology, Soochow University, Suzhou, Jiangsu, China.
Heliyon. 2024 May 21;10(11):e31668. doi: 10.1016/j.heliyon.2024.e31668. eCollection 2024 Jun 15.
Postoperative sleep disturbance (PSD) occurs frequently in patients who undergo major abdominal surgical procedures. Dexmedetomidine is a promising agent to improve the quality of sleep for surgical patients. We designed this trial to investigate the effects of two different doses of intraoperative dexmedetomidine on the occurrence of PSD in elderly patients who have major abdominal surgery.
In this randomized, double-blind, controlled trial, 210 elderly patients aged ≥65 years will be randomized, with an allocation ratio of 1:1:1, to two dexmedetomidine groups (intraoperative infusion of 0.3 or 0.6 μg/kg/h) and a normal saline placebo group. The primary endpoint is the occurrence of PSD on the first night after surgery, assessed using the Athens Insomnia Scale. The secondary endpoints are (1) the incidence of PSD during the 2nd, 3rd, 5th, 7th, and 30th nights postoperatively; (2) pain at rest and on movement at 24 and 48 h postoperatively, assessed using the Numerical Rating Scale; (3) the incidence of postoperative delirium during 0-7 days postoperatively or until hospital discharge, assessed using the 3-min Confusion Assessment Method; (4) depressive symptoms during 0-7 days postoperatively or until hospital discharge, assessed using the 15-items Geriatric Depression Scale; and (5) quality of recovery on postoperative days 1, 2, and 3, assessed using the 15-items Quality of Recovery Scale. Patients' sleep data will also be collected by Xiaomi Mi Band 7 for further analysis.
The findings of this trial will provide clinical evidence for improving the quality of sleep among elderly patients undergoing major abdominal surgery.
This trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (No. 2023-160). The results will be published in a peer-reviewed journal.
Chinese Clinical Trial Registry (ChiCTR2300073163).
术后睡眠障碍（PSD）在接受大型腹部手术的患者中频繁发生。右美托咪定是一种有望改善手术患者睡眠质量的药物。我们设计了这项试验，以研究两种不同剂量的术中右美托咪定对接受大型腹部手术的老年患者PSD发生情况的影响。
在这项随机、双盲、对照试验中，210名年龄≥65岁的老年患者将按1:1:1的分配比例随机分为两个右美托咪定组（术中输注0.3或0.6μg/kg/h）和一个生理盐水安慰剂组。主要终点是术后第一晚PSD的发生情况，采用雅典失眠量表进行评估。次要终点包括：（1）术后第2、3、5、7和30晚PSD的发生率；（2）术后24小时和48小时静息和活动时的疼痛，采用数字评分量表进行评估；（3）术后0至7天或直至出院期间术后谵妄的发生率，采用3分钟意识模糊评估法进行评估；（4）术后0至7天或直至出院期间的抑郁症状，采用15项老年抑郁量表进行评估；（5）术后第1、2和3天的恢复质量，采用15项恢复质量量表进行评估。患者的睡眠数据也将通过小米手环7收集，以进行进一步分析。
本试验的结果将为改善接受大型腹部手术的老年患者的睡眠质量提供临床证据。
本试验已获得苏州大学附属第一医院伦理委员会批准（编号：2023 - 160）。研究结果将发表在同行评审期刊上。
中国临床试验注册中心（ChiCTR2300073163）。
