Video-assisted thoracoscopic surgery (VATS) is the mainstream minimally invasive procedure in thoracic surgery; However, the high-stress state during the perioperative period and severe postoperative pain often lead to significant disruption of patients' sleep patterns, thereby exacerbating postoperative pain sensitisation and delaying early recovery. Traditional sleep-inducing drugs, primarily benzodiazepines, have significant limitations in the perioperative period of thoracic surgery, including respiratory depression, dizziness and residual central effects, which hinder early ambulation. As a new-generation dual orexin receptor antagonist, Lemborexant exerts its sleep-promoting and anti-stress effects by precisely blocking excessive arousal pathways. Furthermore, it causes no respiratory depression, no hangover-like effects the following day, and does not impair muscle strength or mucus clearance, offering the potential to meet the dual requirements of sleep quality and high safety in Enhanced Recovery After Surgery (ERAS) protocols for thoracic surgery. However, there remains a lack of prospective clinical evidence regarding its application in the high-stress, high-pain perioperative acute cohort of thoracoscopic surgery. This study aims to conduct a prospective, randomised, double-blind, placebo-controlled clinical trial to improve perioperative sleep quality in VATS patients. The primary outcome measure of the study was the difference in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total Richards-Campbell Sleep Questionnaire (RCSQ) score on the night of surgery. The study aims to investigate the causal relationship between short-term perioperative Lemborexant intervention and improvements in patient sleep and postoperative recovery quality. The anticipated results will provide clinical evidence of the safety and efficacy of Lemborexant for use in high-stress populations during the perioperative period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
130
The intervention group will take Lemborexant tablets three times during the perioperative period
The control group will take placebo tablets with the same appearance, smell and properties as the intervention group three times during the perioperative period
The incidence of postoperative sleep disturbance (PSD)
Differences in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total score on the Richards-Campbell Sleep Questionnaire (RCSQ). The scale comprises five core items evaluating distinct sleep domains: sleep depth, sleep latency, frequency of awakenings, ability to return to sleep, and overall sleep quality. Each item is rated on a 100-mm visual analogue scale (VAS). The total score is calculated as the mean of the five core item scores, yielding a range from 0 to 100. A higher total score indicates better perceived sleep quality. Specifically, a score of 0 represents the worst possible sleep, while a score of 100 represents the best possible sleep.
Time frame: The first night after the operation
Objective sleep quality
Total sleep time (TST) and wake time after sleep onset (WASO) as monitored by the Huawei sleep tracker.
Time frame: From the night before surgery to the second night after surgery (three consecutive nights).
Postoperative pain scores
Resting pain (NRS-R) and movement-induced pain (NRS-C) at 24 and 48 hours postoperation. Assessment was carried out using a numerical rating scale for pain intensity.
Time frame: At 24 and 48 hours postoperation
Postoperative anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) was used to assess changes in perioperative anxiety and depression subscale scores compared with baseline values.
Time frame: The day before the operation and on the third day after the operation, or upon discharge
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.