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Effect of Esketamine on Postoperative Sleep in Postmenopausal Women
Sponsor: Zhuan Zhang
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. 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.
Key Details
Gender
FEMALE
Age Range
45 Years - Any
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2026-03-01
Completion Date
2026-12-31
Last Updated
2026-03-17
Healthy Volunteers
No
Interventions
Esketamine
Participants in Group E are administered esketamine with an infusion dose of 0.1 ml·kg-¹·h-¹ (0.2 mg·kg-¹·h-¹, diluted with 0.9% sodium chloride in a 2 mg/mL.
Normal Saline
In Group C, 0.9% sodium chloride with a maintenance dose of 0.1 ml·kg-¹·h-¹ are administered intravenously.
Locations (2)
Jingjiang People's Hospital Affiliated to Yangzhou University, Yangzhou University
Jingjiang, Jiangsu, China
The Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu, China