Effect of Esketamine on Postoperative Sleep in Postmenopausal Women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the effect of esketamine versus normal saline on postoperative sleep in postmenopausal women undergoing elective lower-limb fracture surgery under general anesthesia. Eligible participants are women aged 45 or older, postmenopausal for at least 12 months, with ASA I-III, and BMI 18-28. The trial focuses on sleep outcomes and circadian rhythm metrics in the early postoperative period, with esketamine as the active intervention and saline as the control. Subjects will be screened to exclude preexisting sleep disorders, psychotropic use, and other factors that could confound sleep measurements. The goal is to determine whether esketamine can stabilize circadian rhythm and improve sleep parameters after surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status I-III.
2. Aged ≥ 45 years.
3. Women with natural menopause (aged ≥ 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/m².

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.

Where it's running

• Jingjiang People's Hospital Affiliated to Yangzhou University, Yangzhou University
  Jingjiang, Jiangsu, China Recruiting
• The Affiliated Hospital of Yangzhou University, Yangzhou University
  Yangzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhuan Zhang, MD
• Email: zhangzhuancg@163.com
• Phone: +86-15062791355

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.