Jian Minyu, Chen Yiwei, Wang Shuo, Zhou Yang, Liu Haiyang, Liang Fa, Han Ruquan, Wang Huiwen
Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
BMJ Open. 2025 Mar 4;15(3):e090089. doi: 10.1136/bmjopen-2024-090089.
Postoperative sleep disturbance (PSD) is a common complication after spinal surgery that can be related to postsurgical pain, perioperative anxiety and depression. Recent studies have shown that esketamine may improve sleep disturbance after surgery; however, it remains unclear whether intraoperative infusion of esketamine can improve the postoperative sleep quality of patients undergoing spinal surgery.
This is a protocol for a randomised, double-blinded, placebo-controlled clinical trial to evaluate the effect of esketamine on PSD in patients undergoing spinal surgery. Patients aged 18-65 years who plan to undergo selective spinal surgery will be randomly allocated to the esketamine group or control group at a ratio of 1:1. Esketamine or saline will be infused at the same speed of 0.3 mg/kg/hour during the surgery by the anaesthesiologists in charge, who are blinded to the randomisation. The primary outcome of the study is the incidence of PSD during the first 3 days after surgery. The secondary outcomes include objective sleep quality, numeric rating scale scores, dosage of analgesics and Hospital Anxiety and Depression Scale scores.
The study was approved by the Ethical Committee of Beijing Tiantan Hospital, Capital Medical University (KY2024-013-02),Beijing, China. The study was registered on ClinicalTrials.gov on 4 June 2024 (NCT06451627). Our study might guide perioperative anaesthesia management plans and improve PSD in patients undergoing spinal surgery. The findings of the study will be published in peer-reviewed journals and will be presented at national or international conferences.
NCT06451627.
术后睡眠障碍（PSD）是脊柱手术后常见的并发症，可能与术后疼痛、围手术期焦虑和抑郁有关。最近的研究表明，艾司氯胺酮可能改善术后睡眠障碍；然而，术中输注艾司氯胺酮是否能改善脊柱手术患者的术后睡眠质量仍不清楚。
这是一项随机、双盲、安慰剂对照临床试验方案，旨在评估艾司氯胺酮对脊柱手术患者PSD的影响。计划接受选择性脊柱手术的18至65岁患者将按1:1的比例随机分配至艾司氯胺酮组或对照组。负责麻醉的麻醉医生在对随机分组不知情的情况下，于手术期间以0.3mg/kg/小时的相同速度输注艾司氯胺酮或生理盐水。该研究的主要结局是术后前3天PSD的发生率。次要结局包括客观睡眠质量、数字评定量表评分、镇痛药用量以及医院焦虑抑郁量表评分。
该研究已获得首都医科大学附属北京天坛医院伦理委员会批准（KY2024 - 013 - 02），中国北京。该研究于2024年6月4日在ClinicalTrials.gov上注册（NCT06451627）。我们的研究可能会指导围手术期麻醉管理方案，并改善脊柱手术患者的PSD。该研究结果将发表在同行评审期刊上，并在国内或国际会议上展示。
NCT06451627。
