Clinical Research Directory

Perioperative EEG Prediction of Postoperative Sleep Disturbance in Gynecologic Laparoscopic Surgery

Postoperative sleep disturbance is common in patients undergoing gynecologic surgery and may affect postoperative recovery. This prospective observational cohort study will evaluate perioperative EEG changes in patients undergoing gynecologic laparoscopic surgery and examine their association with postoperative sleep disturbance. Approximately 300 adult patients will be enrolled. Frontal EEG will be recorded during the perioperative period, and relevant clinical information will be collected. Postoperative sleep and recovery will be assessed using standardized questionnaires. EEG features and clinical variables will then be analyzed to determine which factors are associated with postoperative sleep disturbance and whether their combination can be used for early risk prediction. The study is intended to characterize perioperative EEG features associated with postoperative sleep disturbance and to develop a clinically applicable risk prediction model. No study-specific treatment or intervention will be assigned to participants.

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.

Effect of Esketamine on Postoperative Sleep in Postmenopausal Women

The prevalence of sleep disturbance among postmenopausal women has been reported to reach 51.6%. Epidemiological studies consistently show that the incidence of sleep disorders increases with age and menopausal transition. Compared with premenopausal women, postmenopausal women demonstrate reduced circadian rhythm stability and a higher prevalence of sleep disturbance. In this population, levels of melatonin, total sleep time, sleep latency, N3 stage sleep, and the circadian amplitude of alertness are all diminished. Sleep disturbance can adversely affect both the mental and physical health of women and significantly impair their social functioning. Poor sleep is associated with decreased cognitive performance and heightened emotional distress, contributing to diminished quality of life. Circadian rhythms are endogenous physiological and behavioral cycles that oscillate over approximately 24 hours, governing critical processes such as sleep-wake cycles, hormonal fluctuations (e.g., cortisol and melatonin). These rhythms are regulated by the suprachiasmatic nucleus (SCN). Disruptions in circadian rhythms have been associated with sleep disturbances. Esketamine is the S (+) enantiomer of ketamine and has a higher affinity for the NMDA receptor than the R-enantiomer. Previous studies have demonstrated that intraoperative administration of esketamine can improve postoperative sleep quality and reduce the incidence of postoperative sleep disturbances, through its antidepressant efficacy, anti-inflammatory properties, analgesic efficacy, neurocognitive and anxiolytic effects. However, few studies have investigated whether esketamine can regulate perioperative circadian rhythms and subsequently affect sleep, especially in postmenopausal women. The objective of this multi-center, prospective, randomized controlled clinical trial is to investigate the effects of esketamine on postoperative sleep in postmenopausal women.

Dynamic Prediction of Sleep Protection Demand on the First Postoperative Night and Its Influence on Ward Process After Thoracoscopic Lobectomy or Segmentectomy

This study combines retrospective data analysis with a single-center prospective non-interventional cohort study to understand postoperative sleep disturbance on the first night after video-assisted thoracoscopic (VATS) lobectomy or segmentectomy. It mainly wants to answer the question: Can perioperative data collected along the clinical timeline dynamically predict which patients will experience clinically significant sleep disturbance on their first postoperative night? Participants undergoing elective VATS lung resection will have multidimensional data systematically collected from preoperative screening (including PSQI and GAD-7), intraoperative anesthetic parameters, PACU-to-ward handover, pre-bedtime symptom burden, and follow-up through 1 month. Three dynamic prediction models (M0 preoperative screening, M1 early postoperative update, and M2 pre-bedtime main model) will be developed using logistic regression with RCSQ-assessed sleep disturbance as the primary outcome, while an explanatory model will quantify the impact of nighttime disruptions such as intravenous infusions, vital sign monitoring, nursing entries, and awakenings.

Transcutaneous Electrical Acupoint Stimulation for Perioperative Sleep Disturbances in Cancer Patients

Postoperative sleep disturbance (POSD) is highly prevalent among cancer patients after tumor resection, affecting 43%-80% of perioperative individuals. Poor sleep aggravates postoperative pain, anxiety and adverse cardiovascular events, hindering postoperative recovery. Conventional hypnotic medicines carry potential risks of drug dependence and respiratory depression. Transcutaneous Electrical Acupoint Stimulation (TEAS) is a non-invasive physical therapy derived from traditional acupuncture, which delivers low-frequency electrical stimulation on acupoints. Previous small-scale researches suggest TEAS may improve perioperative sleep, but high-quality randomized controlled trial evidence for cancer surgical patients is insufficient. This single-center randomized sham-controlled trial aims to verify whether perioperative TEAS at Shenmen (HT7), Neiguan (PC6) and Hegu (LI4) can improve postoperative sleep quality, relieve surgical pain and regulate stress hormone level. A total of 176 eligible patients aged 18-75 years undergoing elective gastrointestinal or gynecologic cancer resection under general anesthesia will be enrolled and randomly divided into 1:1 intervention group and sham control group. The TEAS group receives acupoint electrical stimulation from pre-anesthesia to the end of surgery, while control group uses identical electrodes without actual electrical output. All subjects receive standardized anesthesia and routine postoperative analgesia. Researchers evaluate primary outcomes including PSQI and AIS sleep scales, alongside secondary indicators such as VAS pain score, QoR-15 and serum cortisol at postoperative Day1, Day3, Day7 and postoperative 30-day follow-up.

Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery

This randomized controlled trial aims to evaluate the effects of Autonomous Sensory Meridian Response (ASMR) and white noise on postoperative sleep quality in patients undergoing elective lower extremity surgery. Postoperative sleep disturbances are common after orthopedic surgery and may negatively affect pain perception, recovery, and overall patient outcomes. Participants will be randomly assigned to one of three groups: ASMR intervention, white noise intervention, or control group. Patients in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative period, while the control group will receive routine care with headphones only. Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). The study aims to determine which non-pharmacological intervention is more effective in improving postoperative sleep quality.

Dexmedetomidine Premedication for Post-anaesthesia Sleep Disturbance

The goal of this clinical trial is to learn about the effect of preoperative nasal spry with dexmedetomidine on postoperative sleep disturbance in young to middle-aged women undergoing hysteroscopy. The main questions it aims to answer are:1) what is the incidence of postoperative sleep disturbance in unisex patients who receive propofol anesthesia. 2) The preventive effect of preanesthesia nasal spray dexmedetomidine on postoperative sleep disturbance. Participants will receive total intravenous propofol anaesthesia after dexmedetomidine nasal spray. Sleep quality will be monitored by using a Wearable devices and the PSQI which was used to assess sleep quality 1,2 days before the surgery and 1,3,7 days after surgery. Researchers will compare the effects of 0.2 or 0.5 ug/kg dexmedetomidine to see if it help improve postanesthesia sleep quality.