Effect of Subanesthetic Dose of Esketamine on Sleep Quality

Condition(s) studied

Investigational drug(s) / intervention(s)

Esketamine at low dose: After the induction of general anesthesia, patients in the esketamine group will receive a continuous infusion of esketamine (0.3 mg/kg/h) until the end of the operation.

Normal Saline (0.9% NaCl): After the patient's general anesthesia induction is completed, normal saline will be continuously infused until the end of the operation, and the infusion volume is the same as that of the esketamine group.

Study summary

The goal of this clinical trial is to explore whether subanesthetic doses of esketamine can improve the sleep quality of patients undergoing modified radical mastectomy for breast cancer. In this study, 184 people are expected to participate from admission to three days after surgery.

The process requires participants to cooperate with the completion of the digital rating scale, the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, the Hospital Anxiety and Depression Rating Scale, and the collection of venous blood for research indicators (IL-6, TNF-α, cor, BDNF).

If participants agree to participate in this study, the investigators will assign a unique identification number to each participant and create a medical record for participants.

One day before surgery, the investigators will conduct assessments using the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale, and collect approximately 6 mL of venous blood.

One day after surgery, the investigators will repeat the assessments using the Athens Insomnia Scale, the Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale. Additionally, the investigators will collect another 6 mL of venous blood and monitor the use of analgesics.

The investigators will follow up with participants three days after the surgery. During this follow-up, investigators will assess any sleep disturbances, administer the Hospital Anxiety and Depression Scale, and review the use of analgesics.

Eligibility

Primary outcome measure(s)

• The incidence of PSD on postoperative day -1 — the first day after surgery
  On the first day after surgery, NRS ≥ 6 or AIS ≥ 6.PSD is defined as a numeric rating scale (NRS) ≥6 or Athens Insomnia Scale (AIS) ≥6, indicating that sleep is repeatedly disturbed or worse throughout the night. NRS scores range from 0 to 10, with 0 representing excellent or good sleep and 10 representing inability to sleep all night. AIS consists of 8 items: nighttime awakenings, sleep induction, final awakening, total sleep time, sleep quality, well-being, functional ability, and daytime sleepiness.

Trial sites (1)

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