Wang Jing, Wang Xuyang, Li Sijie, Yang Jinrong, Yan Xiang, Gao Jie, Jia Xiuqin, Zuo Long, Wu Anshi, Wei Changwei
Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti Nanlu, Chao-Yang District, Beijing, 100020, China.
Department of Cardiac Surgery, Beijing Chao-Yang Hospital, Capital Medical University, No.8 Gongti Nanlu, Chao-Yang District, Beijing, 100020, China.
Trials. 2025 Jul 24;26(1):253. doi: 10.1186/s13063-025-08988-3.
Perioperative neurocognitive disorders (PND) is one of the most common postoperative complications among elderly patients (above 65 years old) undergoing cardiac surgery. However, thus far, there have not been any effective therapies for managing PND. Recent research has shown that repetitive transcranial magnetic stimulation (rTMS) alters brain plasticity and improves cognitive function in several neurodegenerative disorders and psychiatric disorders. However, the potential benefits of rTMS in reducing PND in patients undergoing cardiac surgery have not been investigated. Therefore, the current protocol is designed to determine whether rTMS can reduce the incidence of PND in patients undergoing cardiac surgery.
The study will be a single-blinded, randomized controlled trial. Participants undergoing elective cardiac surgery will be randomized to receive either rTMS or sham stimulation with focal figure-of-eight coils over the right dorsolateral prefrontal cortex. A series of neuropsychological tests will be completed to evaluate cognitive function in surgery patients before, on day 7, and on day 30 after cardiac surgery. The primary outcome is the prevalence of PND in cardiac surgery patients. The secondary outcomes will be the incidence of postoperative delirium, pain, sleep quality, depressive symptoms, activities of daily living, length of hospital stay and ICU length of stay, and rate of complication and mortality during the hospital stay.
Beijing Chaoyang Hospital Ethics Committee approved this study and has the number 2022-ke-487. It is registered with Clinical Trials (trial number NCT05668559). Informed consent must be provided by all participants. The study result will be published in a peer-reviewed journal.
NCT05668559. Registered on June 6, 2022.
围手术期神经认知障碍（PND）是接受心脏手术的老年患者（65岁以上）中最常见的术后并发症之一。然而，迄今为止，尚无治疗PND的有效疗法。最近的研究表明，重复经颅磁刺激（rTMS）可改变脑可塑性，并改善多种神经退行性疾病和精神疾病的认知功能。然而，rTMS在降低心脏手术患者PND方面的潜在益处尚未得到研究。因此，本研究方案旨在确定rTMS是否能降低心脏手术患者PND的发生率。
本研究将是一项单盲随机对照试验。接受择期心脏手术的参与者将被随机分配，通过置于右侧背外侧前额叶皮质的局部8字形线圈接受rTMS或假刺激。将在心脏手术前、术后第7天和第30天完成一系列神经心理学测试，以评估手术患者的认知功能。主要结局是心脏手术患者中PND的患病率。次要结局将包括术后谵妄的发生率、疼痛、睡眠质量、抑郁症状、日常生活活动能力、住院时间和重症监护病房住院时间，以及住院期间的并发症发生率和死亡率。
北京朝阳医院伦理委员会批准了本研究，编号为2022-ke-487。该研究已在临床试验注册（试验编号NCT05668559）。所有参与者均须提供知情同意书。研究结果将发表在同行评审期刊上。
NCT-05668559。于2022年6月6日注册。
