Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery

NCT07811401 | Not Yet Recruiting Phase 2

• 1 other identifier: LV-20260903
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Sleep Disturbance; Thoracoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  The first night after the operation

Secondary Outcomes (3)

• Objective sleep quality

  From the night before surgery to the second night after surgery (three consecutive nights).

• Postoperative pain scores

  At 24 and 48 hours postoperation

• Postoperative anxiety and depression

  The day before the operation and on the third day after the operation, or upon discharge

Study Arms (2)

lemborexant

EXPERIMENTAL

the intervention group

Drug: Lemborexant 5 mg

placebo

PLACEBO COMPARATOR

the control group

Drug: Placebo

Interventions

Lemborexant 5 mg DRUG

The intervention group will take Lemborexant tablets three times during the perioperative period

lemborexant

Placebo DRUG

The control group will take placebo tablets with the same appearance, smell and properties as the intervention group three times during the perioperative period

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Interventions

lemborexant

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09