An interventional study of Esketamine and Normal Saline in Circadian Rhythm and Postoperative Sleep Disturbance, sponsored by Zhuan Zhang. Recruiting at 2 sites in China. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Zhuan Zhang · Not applicable, Interventional, and Prevention
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.
Zhuan Zhang is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Esketamine
Drug: Normal Saline
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.
In Group C, 0.9% sodium chloride with a maintenance dose of 0.1 ml·kg-¹·h-¹ are administered intravenously.
The incidence of postoperative sleep disturbance (PSD) on 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.
Time frame: Postoperative day 1.
Biological rhythm detection
Melatonin and cortisol rhythm profiles are analyzed using saliva samples every 6 h for 48 h: at 10:00 PM on the night of surgery; 4:00 AM, 10:00 AM, 4:00 PM, and 10:00 PM on postoperative day 1; and 4:00 AM and 10:00 AM on postoperative day 2. Expression of core circadian clock genes, serum melatonin and cortisol concentrations are assessed on preoperative day 1, postoperative day 1 and postoperative day 3.
Time frame: From preoperative day 1 to postoperative day 3.
Objective sleep parameters recorded by actigraphy
Objective sleep parameters are recorded using actigraphy.The parameters include total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), proportion of WASO (WASO%), and sleep efficiency (SE%).
Time frame: From preoperative night 1 to postoperative night 3.
Subjective sleep quality
The Pittsburgh Sleep Quality Index (PSQI) is assessed on the day before surgery and 30 days postoperatively. Self-rated sleep quality is evaluated using the NRS and the AIS on the day before surgery and on postoperative days 2 and 3.
Time frame: From preoperative day 1 to postoperative day 30.
Anxiety and Depression assessments
Anxiety and depression are measured using the Hospital Anxiety and Depression Scale (HADS). It comprises two subscales: the Anxiety subscale (HADS-A) and the Depression subscale (HADS-D). For each item, respondents select the degree of severity, ranging from 0 to 3, representing none, mild, moderate, and severe. The total score for each subscale ranges from 0 to 21, with higher scores indicating more severe anxiety or depression symptoms. Scores of 0-7 are considered normal, 8-10 suggest the possibility of mild anxiety or depression, 11-14 indicate the possibility of moderate anxiety or depression, and 15-21 signify the possibility of severe anxiety or depression.
Time frame: From preoperative day 1 to postoperative day 3.
Frontal electroencephalography
Electroencephalogram (EEG) data is collected using the ConView Anesthesia Depth Monitoring System (ConView YY-105, Zhejiang Puke Medical Technology Co., Ltd., China). The analysis includes the power spectrum of EEG energy across various frequency bands, the peak frequencies in the α-β band, and key electrocorticogram indices such as the left α-index (Aileft), right α-index (Airight), electromyographic index (EMG), and burst suppression ratio (BSR).
Time frame: From entering the operating room to surgery ending.
Postoperative cognitive function and biomarkers
Delirium assessments is conducted twice daily on postoperative days 1, 2, and 3 with at least 6 hours interval between evaluations, using the Chinese version of the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM). Brain-derived neurotrophic factor (BDNF) and S100-β are measured from blood samples collected on preoperative day 1, postoperative day 1 and postoperative day 3.
Time frame: From preoperative day 1 to postoperative day 3.
Inflammatory markers
Inflammatory biomarkers including tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, IL-6, and IL-10 are measured.
Time frame: From preoperative day 1 to postoperative day 3.
Postoperative pain assessment
Pain levels, including both rest and exercise pain, are measured using the Visual Analogue Scale (VAS) at 24 hours, 48 hours, and 72 hours postoperatively. Data on the use of the Patient-Controlled Analgesia (PCIA) device, including trigger times for bolus doses within the first 24 hours post-surgery, the total number of bolus presses, and the use of the rescue analgesic flurbiprofen, are documented.
Time frame: From postoperative day 1 to day 3.
Possible adverse reactions
Time frame: From esketamine infusion to postoperative day 3.
Quality of postoperative recovery
The QoR-15 score is used to assess the quality of recovery. The QoR-15 includes five dimensions: physical comfort, physical independence, emotional state, pain, and psychological support, with a total of 15 questions. Each question is scored from 0 to 10, with a higher score indicating better recovery quality.
Time frame: From postoperative day 1 to day 3.
The length of hospital stay
Time frame: From the date of hospital admission to the date of discharge.
Plan to share: No
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Studies of the drug tested here: Esketamine
Zhuan Zhang