Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands
Neuroscience, Erasmus MC, Rotterdam, The Netherlands.
BMJ Open. 2021 Oct 1;11(10):e048270. doi: 10.1136/bmjopen-2020-048270.
Delirium is a neurocognitive disorder characterised by an acute and temporary decline of mental status affecting attention, awareness, cognition, language and visuospatial ability. The underlying pathophysiology is driven by neuroinflammation and cellular oxidative stress.Delirium is a serious complication following neurosurgical procedures with a reported incidence varying between 4% and 44% and has been associated with increased length of hospital stay, increased amount of reoperations, increased costs and mortality.Perioperative music has been reported to reduce preoperative anxiety, postoperative pain and opioid usage, and attenuates stress response caused by surgery. We hypothesize that this beneficial effect of music on a combination of delirium eliciting factors might reduce delirium incidence following neurosurgery and subsequently improve clinical outcomes.
This protocol concerns a single-centred prospective randomised controlled trial with 6 months follow-up. All adult patients undergoing a craniotomy at the Erasmus Medical Center in Rotterdam are eligible. The music group will receive recorded music through an overear headphone before, during and after surgery until postoperative day 3. Patients can choose from music playlists, offered based on music importance questionnaires administered at baseline. The control group will receive standard of clinical careDelirium is assessed by the Delirium Observation Scale and confirmed by a delirium-expert psychiatrist according to the DSM-5 criteria. Risk factors correlated with the onset of delirium, such as cognitive function at baseline, preoperative anxiety, perioperative medication use, depth of anaesthesia and postoperative pain, and delirium-related health outcomes such as length of stay, daily function, quality of life (ie, EQ-5D, EORTC questionnaires), costs and cost-effectiveness are collected.
This study is being conducted in accordance with the Declaration of Helsinki. The Medical Ethics Review Board of Erasmus University Medical Center Rotterdam, The Netherlands, approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations.
NL8503 and NCT04649450.
谵妄是一种以注意力、意识、认知、语言和视空间能力急性和暂时下降为特征的神经认知障碍。其潜在的病理生理学是由神经炎症和细胞氧化应激驱动的。谵妄是神经外科手术后的一种严重并发症，其报告发病率在 4%至 44%之间，与住院时间延长、再手术次数增加、成本增加和死亡率增加有关。围手术期音乐已被报道可降低术前焦虑、术后疼痛和阿片类药物使用，并减轻手术引起的应激反应。我们假设音乐对一系列诱发谵妄的因素的这种有益影响可能会降低神经外科手术后谵妄的发生率，并随后改善临床结果。
这是一项单中心前瞻性随机对照试验，随访 6 个月。所有在鹿特丹伊拉斯谟医疗中心接受开颅手术的成年患者均符合入选标准。音乐组将在手术前、手术中和手术后直到术后第 3 天通过头戴式耳机播放录制的音乐。患者可以根据基线时进行的音乐重要性问卷选择音乐播放列表。对照组将接受标准的临床护理。谵妄通过谵妄观察量表进行评估，并根据 DSM-5 标准由谵妄专家精神病医生确认。与谵妄发作相关的风险因素，如基线时的认知功能、术前焦虑、围手术期用药、麻醉深度和术后疼痛，以及谵妄相关的健康结果，如住院时间、日常功能、生活质量（即 EQ-5D、EORTC 问卷）、成本和成本效益，都将被收集。
本研究符合《赫尔辛基宣言》的规定。荷兰鹿特丹伊拉斯谟大学医学中心的医学伦理审查委员会批准了本方案。结果将通过同行评议的科学期刊和会议报告进行传播。
NL8503 和 NCT04649450。
