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Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery

StatusNot Yet Recruiting
PhasePhase 2
Started2026-10-08
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07811401
Lead Sponsor Beijing Tiantan Hospital
Conditions Postoperative Sleep Disturbance, Thoracoscopic Surgery
Enrollment 130 participants
Start Date 2026-10-08
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-10