Effect of Esketamine on Postoperative Sleep in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 4
- 主要终点
- The incidence of postoperative sleep disturbance (PSD) on postoperative day 1.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Aged ≥ 45 years.
- •Women with natural menopause (aged ≥ 45 years and postmenopause for more than 12 months without surgical or medical intervention) .
- •Scheduled to undergo elective lower-limb fracture surgery with an expected duration of more than 60 min under general anesthesia.
- •Body Mass Index (BMI) between 18 and 28 kg/m².
排除标准
- •Presence of preoperative sleep-related disorders, such as obstructive sleep apnea or restless legs syndrome.
- •History of drug or alcohol abuse or dependence.
- •Known contraindications or allergies to esketamine or other anesthetic agents.
- •Use of psychotropic medications or sex hormones within the past 3 months.
- •Shift work or taking medications affecting melatonin.
- •Severe comorbid conditions, including but not limited to uncontrolled hypertension, coronary artery disease, cardiac insufficiency, pulmonary hypertension, intracranial hypertension or elevated intraocular pressure, hyperthyroidism, severe hepatic or renal dysfunction.
- •History of cerebral infarction, intracerebral hemorrhage, or residual central nervous system deficits.
- •Impairments of language, hearing, vision, or cognitive function that would prevent completion of questionnaires or cooperation with sleep monitoring.
- •Active oral pathologies.
- •Transfer to ICU postoperatively.
研究组 & 干预措施
Control Group (Group C)
干预措施: Normal Saline (Drug)
Esketamine Group (Group E)
干预措施: Esketamine (Drug)
结局指标
主要结局
The incidence of postoperative sleep disturbance (PSD) on postoperative day 1.
时间窗: Postoperative day 1.
The primary outcome is the incidence of PSD, evaluated using the Numeric Rating Scale (NRS) and the Athens Insomnia Scale (AIS) on postoperative day 1. PSD is defined as an NRS score of 6 or higher or an AIS score of 6 or higher.
次要结局
- Frontal electroencephalography(From entering the operating room to surgery ending.)
- Inflammatory markers(From preoperative day 1 to postoperative day 3.)
- Biological rhythm detection(From preoperative day 1 to postoperative day 3.)
- Postoperative cognitive function and biomarkers(From preoperative day 1 to postoperative day 3.)
- Postoperative pain assessment(From postoperative day 1 to day 3.)
- Objective sleep parameters recorded by actigraphy(From preoperative night 1 to postoperative night 3.)
- Subjective sleep quality(From preoperative day 1 to postoperative day 30.)
- Anxiety and Depression assessments(From preoperative day 1 to postoperative day 3.)
研究者
Zhuan Zhang
MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou University