Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Tiantan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Lemborexant 5 mg
DrugThe intervention group will take Lemborexant tablets three times during the perioperative period
Placebo
DrugThe control group will take placebo tablets with the same appearance, smell and properties as the intervention group three times during the perioperative period
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: lemborexantExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
The first night after the operationSecondary outcomes
1
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).2
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 postoperation3
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 dischargeLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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