Actively Recruiting
Effect of Subanesthetic Dose of Esketamine on Sleep Quality
Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-02-10
184
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Subanesthetic Dose of Esketamine on Sleep Quality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with breast cancer confirmed by pathology and immunohistochemistry
- Receiving neoadjuvant chemotherapy
- Age between 18 and 65 years old
- ASA grade I to III
- Body mass index (BMI) between 18 and 30 kg/m2
You will not qualify if you...
- Refusal to participate in the study
- Body mass index (BMI) greater than 30 kg/m2
- Recent history of drug abuse
- Allergy or contraindication to esketamine
- Cognitive dysfunction or inability to communicate
- Severe dysfunction of important organs such as liver or kidneys
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006
Actively Recruiting
Research Team
W
wenwen zhang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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