Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
NCT06773143

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

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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