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Not Yet Recruiting NCT07811401

Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery

Conditions: Postoperative Sleep Disturbance, Thoracoscopic Surgery

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 130
Sponsor: Beijing Tiantan Hospital

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Aged between 18 and 70 years; * ASA I-III; * Patients scheduled to undergo elective video-assisted thoracoscopic surgery (VATS) under general anaesthesia, including wedge resection, segmentectomy and lobectomy; * Expected post-operative hospital stay of ≥3 days; * Signing of a written informed consent form. Exclusion Criteria: * Patients whose surgery is expected to finish after 19:00, or who will remain intubated post-operatively or require admission to the ICU; * Patients with a pre-operative diagnosis of moderate to severe obstructive sleep apnoea (OSA); * Patients with pre-existing sleep disorders or those taking sedatives, hypnotics or antidepressants on a long-term basis; * Patients with moderate to severe hepatic or renal impairment; * Patients with cognitive impairment preventing them from cooperating with scale-based assessments; * Patients with pre-existing chronic neuropathic pain; * Patients unsuitable for or refusing to participate in this study for other. reasons.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07811401). StuddyBuddy aggregates publicly available trial information.