Effect of Subanesthetic Dose of Esketamine on Sleep Quality

Recruiting now · Not applicable

Conditions studied: Insomnia, Breast Cancer Surgery, Esketamine

In brief

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.

Key facts

Study ID

NCT06773143

Run by

Nanjing First Hospital, Nanjing Medical University

People needed

184

Starts

2024-12-30

Expected to finish

2027-04-30

Last updated by the study team

2025-02-10

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients diagnosed with breast cancer by pathology and immunohistochemistry
• Patients receiving neoadjuvant chemotherapy
• Age 18 to 65 years old; d) ;
• ASA grade Ⅰ - Ⅲ
• BMI 18 to 30 kg/m2

You may not qualify if…

• 1: Patients refuse to participate in the study
• 2: BMI > 30 kg/m2
• 3: Recent history of drug abuse
• 4: Allergy to or contraindications to esketamine
• 5: Cognitive dysfunction or inability to communicate
• 6: Severe dysfunction of important organs such as liver and kidney function

Where it is running

• Nanjing First Hospital — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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