RecruitingNot ApplicableNCT06773143

Effect of Subanesthetic Dose of Esketamine on Sleep Quality

Effect of Subanesthetic Dose of Esketamine on Sleep Quality in Patients With Breast Cancer After Chemotherapy


Sponsor

Nanjing First Hospital, Nanjing Medical University

Enrollment

184 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a low dose of esketamine (a fast-acting anesthetic drug sometimes used for depression and pain) given before surgery improves sleep quality in breast cancer patients receiving neoadjuvant chemotherapy (chemotherapy before surgery). **You may be eligible if...** - You have breast cancer confirmed by pathology and immunohistochemistry testing - You are currently receiving neoadjuvant (pre-surgery) chemotherapy - You are 18–65 years old - You have a BMI between 18 and 30 - Your overall health is classified as ASA I-III **You may NOT be eligible if...** - You refuse to participate - Your BMI is above 30 - You have a known allergy or contraindication to esketamine - You have cognitive dysfunction or are unable to communicate - You have severe liver or kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsketamine 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.

OTHERNormal 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.


Locations(1)

Nanjing First Hospital

Nanjing, Jiangsu, China

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NCT06773143


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