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前额叶交流电刺激对妇科腹腔镜手术患者术后睡眠障碍的预防作用:一项随机、双盲、假刺激对照试验

Prophylactic Effect of Prefrontal Alternating Current Stimulation on Postoperative Sleep Disturbance in Patients Undergoing Gynecological Laparoscope: A Randomized, Double-Blind, Sham-Controlled Trial.

作者信息

Du Ni, Yang Jin-Jin, Li Xin-Yu, Li Zhi-Hao, Hashimoto Kenji, Lei Lei, Yang Jian-Jun

机构信息

Department of Anesthesiology, Pain and Perioperative Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.

Henan Province International Joint Laboratory of Pain, Cognition, and Emotion, Zhengzhou, China.

出版信息

CNS Neurosci Ther. 2025 Aug;31(8):e70529. doi: 10.1111/cns.70529.

Abstract

AIMS

Postoperative sleep disturbance (PSD) is a common complication following surgical procedures. We aimed to evaluate the effect of prefrontal transcranial alternating current stimulation (tACS) in preventing PSD among patients undergoing gynecological laparoscopic surgery.

METHODS

A total of 176 eligible patients, aged 18-65 years, with ASA Class I to III, and scheduled for gynecological laparoscopic surgery, were randomly allocated to receive either a single 20-min session of prefrontal tACS (2 mA, 7 Hz) or sham stimulation immediately after extubation. The primary outcome was the occurrence of PSD on postoperative day (POD) 1.

RESULTS

The intention-to-treat analysis showed a statistically significant reduction in PSD incidence on POD 1 in the active tACS group (23.9%) compared to the sham group (43.2%), with an odds ratio of 0.41 (95% CI, 0.22-0.79; p = 0.007). Additionally, patients in the active tACS group reported significantly lower anxiety scores on POD 1 (p < 0.001), while depression scores were comparable between the groups. The active tACS group also reported significantly lower pain scores, both on PODs 1 (movement: p = 0.002; rest: p < 0.001) and 3 (movement: p = 0.028; rest: p < 0.001).

CONCLUSIONS

A single session of prefrontal tACS significantly reduces the incidence of PSD on POD 1 and may offer additional benefits in reducing early postoperative anxiety and pain, with a favorable safety and tolerability profile.

TRIAL REGISTRATION

China Clinical Trial Registration Center: ChiCTR2300078658.

摘要

目的

术后睡眠障碍(PSD)是外科手术后常见的并发症。我们旨在评估前额叶经颅交流电刺激(tACS)对妇科腹腔镜手术患者预防PSD的效果。

方法

总共176例年龄在18 - 65岁、ASA分级为I至III级且计划进行妇科腹腔镜手术的符合条件患者,在拔管后立即被随机分配接受单次20分钟的前额叶tACS(2毫安,7赫兹)或假刺激。主要结局是术后第1天(POD 1)PSD的发生情况。

结果

意向性分析显示,与假刺激组(43.2%)相比,主动tACS组在POD 1时PSD发生率有统计学意义的降低,比值比为0.41(95%可信区间,0.22 - 0.79;p = 0.007)。此外,主动tACS组患者在POD 1时焦虑评分显著更低(p < 0.001),而两组间抑郁评分相当。主动tACS组在POD 1(活动时:p = 0.002;静息时:p < 0.001)和POD 3(活动时:p = 0.028;静息时:p < 0.001)时疼痛评分也显著更低。

结论

单次前额叶tACS显著降低了POD 1时PSD的发生率,并且在减轻术后早期焦虑和疼痛方面可能具有额外益处,安全性和耐受性良好。

试验注册

中国临床试验注册中心:ChiCTR2300078658。

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