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NCT Number: NCT07811401

Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery

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.

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Key information

Conditions

Postoperative Sleep Disturbance Thoracoscopic Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lemborexant 5 MG

Drug

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

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

Primary outcomes

  1. The incidence of postoperative sleep disturbance (PSD)

    Time frame: The first night after the operation

    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.

Secondary outcomes

  1. Objective sleep quality

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

    Total sleep time (TST) and wake time after sleep onset (WASO) as monitored by the Huawei sleep tracker.

  2. Postoperative pain scores

    Time frame: At 24 and 48 hours postoperation

    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.

  3. Postoperative anxiety and depression

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

    The Hospital Anxiety and Depression Scale (HADS) was used to assess changes in perioperative anxiety and depression subscale scores compared with baseline values.

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Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

The Effect of Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 10, 2026
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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