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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Nanjing First Hospital
RECRUITING
Nanjing
Contact Information
Primary
wenwen zhang, Dr
1395626955@qq.com
+8615366110306
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 184
Treatments
Experimental: esketamine group
After the patient is induced with general anesthesia, esketamine (0.3 mg/kg/h) will be continuously infused during the operation until the end of the operation.
Placebo_comparator: control group
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.
Related Therapeutic Areas
Sponsors
Leads: Nanjing First Hospital, Nanjing Medical University

This content was sourced from clinicaltrials.gov