Trials · 2026
Transauricular vagus nerve electrical stimulation improves postoperative sleep disorders in elderly patients (VNstep): protocol for a randomized controlled clinical trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Wang Tianyuan, Wu Youxuan, Hou Xuan, Liang Fa, Jian Minyu, Yu Yun, Wang Yunzhen, Liu Haiyang, Han Ruquan
Аннотация
BACKGROUND: Perioperative sleep disorders (PSDs) in elderly patients under general anesthesia are associated with high morbidity and severely affect patients' prognosis. In recent years, vagus nerve electrical stimulation (VNS) has been shown to treat diseases related to autonomic dysfunction, and its anti-inflammatory and other mechanisms may present potential therapeutic possibilities for sleep disorders. This study aimed to investigate the efficacy of transauricular vagal nerve stimulation in improving sleep disorders in elderly patients.
METHODS/DESIGN: This is a single-center, prospective, randomized, controlled clinical trial. A total of 164 elderly patients receiving general anesthesia were randomized at a 1:1 ratio into two groups: one receiving electrical vagus nerve stimulation during the perioperative period and the other receiving sham stimulation. The primary outcome was the incidence of perioperative sleep disorders within 3 days postoperatively, which was defined as an Athens Insomnia Scale (AIS) score of ≥ 6 or a numerical rating scale (NRS) score of ≥ 6. Further effectiveness and safety parameters included sleep quality on days 1, 3, and 5 after surgery, the postoperative pain score, the hospital anxiety‒depression score, the incidence of postoperative delirium, and the incidence of related adverse events.
DISCUSSION: This study aimed to investigate the efficacy and feasibility of using taVNS to improve PSD in elderly patients receiving general anesthesia.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06421051. Registered on May 10, 2024.
PROTOCOL VERSION: 1.0: Date: 2024-05-01.
METHODS/DESIGN: This is a single-center, prospective, randomized, controlled clinical trial. A total of 164 elderly patients receiving general anesthesia were randomized at a 1:1 ratio into two groups: one receiving electrical vagus nerve stimulation during the perioperative period and the other receiving sham stimulation. The primary outcome was the incidence of perioperative sleep disorders within 3 days postoperatively, which was defined as an Athens Insomnia Scale (AIS) score of ≥ 6 or a numerical rating scale (NRS) score of ≥ 6. Further effectiveness and safety parameters included sleep quality on days 1, 3, and 5 after surgery, the postoperative pain score, the hospital anxiety‒depression score, the incidence of postoperative delirium, and the incidence of related adverse events.
DISCUSSION: This study aimed to investigate the efficacy and feasibility of using taVNS to improve PSD in elderly patients receiving general anesthesia.
TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06421051. Registered on May 10, 2024.
PROTOCOL VERSION: 1.0: Date: 2024-05-01.