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Effect of Esketamine on Postoperative Sleep in Postmenopausal Women

RecruitingNAAges 45 Years - anyFemaleZhuan Zhang
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In plain words

What the trial is, and whether it could suit you

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 approximate

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. American Society of Anesthesiologists (ASA) physical status I-III. 2. Aged โ‰ฅ 45 years. 3. Women with natural menopause (aged โ‰ฅ 45 years and postmenopause for more than 12 months without surgical or medical intervention) . 4. Scheduled to undergo elective lower-limb fracture surgery with an expected duration of more than 60 min under general anesthesia. 5. Body Mass Index (BMI) between 18 and 28 kg/mยฒ. Exclusion Criteria: 1. Presence of preoperative sleep-related disorders, such as obstructive sleep apnea or restless legs syndrome. 2. History of drug or alcohol abuse or dependence. 3. Known contraindications or allergies to esketamine or other anesthetic agents. 4. Use of psychotropic medications or sex hormones within the past 3 months. 5. Shift work or taking medications affecting melatonin. 6. 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. 7. History of cerebral infarction, intracerebral hemorrhage, or residual central nervous system deficits. 8. Impairments of language, hearing, vision, or cognitive function that would prevent completion of questionnaires or cooperation with sleep monitoring. 9. Active oral pathologies. 10. Transfer to ICU postoperatively.
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What it tests

  • Esketamine
  • Normal Saline
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Where

2 sites
Jingjiang People's Hospital Affiliated to Yangzhou University, Yangzhou University
Jingjiang, China
The Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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