Effect of Esketamine on Postoperative Sleep in Postmenopausal Women

NCT ID: NCT07315074

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-12-31

Brief Summary

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. Moreover, prolonged sleep deprivation elevates the risk of developing obesity, diabetes, cardiovascular conditions, and psychiatric disorders.

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 circadian rhythms and subsequently affect sleep, especially in postmenopausal women.

The objective of this two-center, prospective, randomized controlled clinical trial is to investigate the effects of esketamine on postoperative sleep in postmenopausal women.

Conditions

Circadian Rhythm; Postoperative Sleep Disturbance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Esketamine Group (Group E)

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

Participants in Group E are administered esketamine with a loading dose of 0.2 mg/kg (diluted to 10 ml with normal saline) and a maintenance dose of 0.2 mg·kg-¹·h-¹ .

Control Group (Group C)

Group Type: PLACEBO_COMPARATOR

Normal Saline

Intervention Type: DRUG

In Group C, a loading dose of normal saline 10 ml and a maintenance dose of 10 ml/h of normal saline is given intravenously.

Interventions

Esketamine

Participants in Group E are administered esketamine with a loading dose of 0.2 mg/kg (diluted to 10 ml with normal saline) and a maintenance dose of 0.2 mg·kg-¹·h-¹ .

Intervention Type: DRUG

Normal Saline

In Group C, a loading dose of normal saline 10 ml and a maintenance dose of 10 ml/h of normal saline is given intravenously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. American Society of Anesthesiologists (ASA) physical status I-III.

2. Postmenopausal women (aged > 40 years, postmenopause for more than 12 months; excluding pregnancy).

3. Aged > 40 years.

4. Scheduled to undergo elective lower-limb fracture surgery under general anesthesia.

5. Body Mass Index (BMI) between 18 and 28 kg/m².

6. Expected surgical duration of ≥ 60 min.

7. Patients who require perioperative urinary catheterization.

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. History of uterine or ovarian surgery.

9. Impairments of language, hearing, vision, or cognitive function that would prevent completion of questionnaires or cooperation with sleep monitoring.

10. Transfer to ICU postoperatively.

• Minimum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhuan Zhang

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Jingjiang People's Hospital

Jingjiang, Jiangsu, China

The Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Central Contacts

Zhuan Zhang, MD

Role: CONTACT

zhangzhuancg@163.com

+86-15062791355

Facility Contacts

Xiang Pu, Master Degree

Role: primary

+86-18951150271

Zhuan Zhang, MD

Role: primary

zhangzhuancg@163.com

+86-15062791355

Other Identifiers

20251115

Identifier Type: -

Identifier Source: org_study_id