Department of Anaesthesiology, Shanghai Cancer Centre, Fudan University, Shanghai, People's Republic of China.
Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People's Republic of China.
BMJ Open. 2024 Feb 27;14(2):e081589. doi: 10.1136/bmjopen-2023-081589.
Postoperative sleep disturbances significantly impair postoperative recovery. The administration of intravenous esketamine has been shown to potentially improve postoperative sleep quality. However, the effectiveness of epidural esketamine in improving postoperative sleep quality remains to be elucidated. This study aims to explore the impact of both intraoperative and postoperative use of epidural esketamine on the postoperative sleep quality of patients undergoing minimally invasive lower abdominal surgeries.
This randomised, double-blind, parallel-group, placebo-controlled trial will be conducted at the Fudan University Shanghai Cancer Centre. A total of 128 adults undergoing minimally invasive lower abdominal surgeries will be randomly allocated in a 1:1 ratio to either the esketamine group or the placebo group. In the esketamine group, epidural esketamine will be administered intraoperatively (0.2 mg/kg) and postoperatively (25 mg). Postoperatively, all patients will receive epidural analgesia. The primary outcome of the study is the incidence of poor sleep quality on the third day after surgery. The sleep quality assessment will be conducted using the Pittsburgh Sleep Quality Index and a Numeric Rating Scale of sleep. The main secondary outcomes include postoperative pain and anxiety and depression scores. The postoperative pain, both rest pain and movement pain, will be assessed using a Numerical Rating Scale within 5 days after surgery. Anxiety and depression scores will be evaluated using the Hospital Anxiety and Depression Scale both before and after the surgery. Safety outcomes will include delirium, fidgeting, hallucinations, dizziness and nightmares. The analyses will be performed in accordance with intention-to-treat principle ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Ethics Committee of the Shanghai Cancer Centre (2309281-9). Prior to participation, all patients will provide written informed consent. The results of the trial are intended to be published in a peer-reviewed journal.
ChiCTR2300076862.
术后睡眠障碍显著影响术后恢复。静脉注射氯胺酮已被证明可能改善术后睡眠质量。然而，硬膜外氯胺酮在改善术后睡眠质量方面的有效性仍有待阐明。本研究旨在探讨术中及术后硬膜外使用氯胺酮对接受微创下腹部手术患者术后睡眠质量的影响。
这是一项在复旦大学附属肿瘤医院进行的随机、双盲、平行组、安慰剂对照试验。将 128 名接受微创下腹部手术的成年人以 1:1 的比例随机分配到氯胺酮组或安慰剂组。在氯胺酮组，术中（0.2mg/kg）和术后（25mg）给予硬膜外氯胺酮。术后所有患者均接受硬膜外镇痛。研究的主要结局是术后第 3 天睡眠质量差的发生率。睡眠质量评估将使用匹兹堡睡眠质量指数和睡眠数字评分量表进行。主要次要结局包括术后疼痛和焦虑抑郁评分。术后疼痛（静息痛和运动痛）将在术后 5 天内使用数字评分量表进行评估。焦虑和抑郁评分将在术前和术后使用医院焦虑和抑郁量表进行评估。安全性结局包括谵妄、烦躁、幻觉、头晕和噩梦。分析将按照意向治疗原则进行。
本研究已获得上海肿瘤医院伦理委员会的批准（2309281-9）。所有患者在参与前均需提供书面知情同意书。试验结果计划发表在同行评议的期刊上。
ChiCTR2300076862。
