Effect of Subanesthetic Dose of Esketamine on Sleep Quality (EOSDOEOSQ)

February 6, 2025 updated by: Nanjing First Hospital, Nanjing Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In 2020, breast cancer became the most common cancer worldwide. Treatment methods for breast cancer include surgery, chemotherapy, and endocrine therapy, with surgery remaining the primary treatment option. The emergence of neoadjuvant chemotherapy has expanded the indications for breast cancer surgery, providing surgical opportunities for patients with late-stage clinical staging and a strong desire for breast preservation. Neoadjuvant chemotherapy has the effects of reducing tumor size, lowering clinical staging, assessing the tumor's sensitivity to chemotherapy drugs, and inhibiting tumor cell proliferation. However, chemotherapy, while treating the disease, also causes numerous adverse reactions that directly or indirectly lead to sleep disturbances in patients.

Sleep disturbances reduce cognitive function, immune function, and quality of life in breast cancer chemotherapy patients, with an incidence of sleep disturbances during chemotherapy reaching 80%. These patients, when undergoing surgery, are highly prone to postoperative sleep disturbances (Postoperative Sleep Disturbance, PSD) due to factors such as preoperative sleep disturbances, fear and anxiety about surgery, inflammatory responses, and pain. This negatively impacts their recovery process.

PSD refers to changes in sleep structure and quality in the early postoperative period. It is a clinical syndrome characterized by disturbances in the sleep-wake rhythm following surgery, leading to abnormal sleep quality or sleep behavior, usually manifesting as reduced rapid eye movement (REM) sleep, prolonged wakefulness, and fragmented sleep. There is no unified standard for the duration of PSD, as it varies according to disease type, surgical procedure, and individual differences. Generally, it occurs within a short time after surgery, such as 1-3 days postoperatively. PSD significantly affects the postoperative circadian rhythm, pain levels, inflammatory responses, cognitive function, and cardiovascular outcomes, leading to prolonged recovery time. Clinically, both pharmacological and non-pharmacological interventions are used, with pharmacological treatments primarily involving benzodiazepines, which increase sleep duration and reduce sleep latency. Studying short-term sleep disturbances helps identify and reduce postoperative complications, such as delirium, infections, and cardiovascular events, thus accelerating recovery, improving patient safety, and promoting multidisciplinary collaboration. However, there is limited research on the preventive improvement of sleep quality.

Esketamine, a non-competitive N-methyl-D-aspartate receptor (NMDA) antagonist, is the right-handed isomer of ketamine. It shares a similar pharmacological mechanism with ketamine, but its potency is higher. The most important effect of esketamine is its ability to inhibit the NMDA receptor-mediated glutamate entry into the GABA nervous system, causing excitability changes in the cortex and limbic system, ultimately leading to loss of consciousness. Sub-anesthetic doses of esketamine (0.5 mg/kg, 40-minute intravenous infusion) have been shown to produce rapid and sustained antidepressant effects in patients with treatment-resistant major depressive disorder (MDD).

Additionally, intravenous administration of esketamine at 0.2-0.4 mg/kg (single infusion over 40 minutes) has demonstrated rapid and potent antidepressant effects in the treatment of refractory depression. Apart from its antidepressant effects, esketamine has been proven to improve sleep disturbances in patients with MDD and sleep issues, suggesting that esketamine has potential as a treatment for sleep disorders. Some studies indicate that the antidepressant effect of esketamine is related to the neurobiological structure of wakefulness, sleep, and circadian rhythms. Animal studies also suggest that esketamine can modulate the NF-κB signaling pathway and oxidative stress, inhibiting the release of downstream inflammatory factors, thereby reducing surgical-induced inflammatory damage and playing an anti-anxiety, antidepressant role to improve postoperative recovery quality. However, it remains unclear whether continuous low-dose infusion of esketamine during surgery can reduce the incidence of PSD. This study aims to investigate the impact of continuous infusion of esketamine during surgery on postoperative sleep quality in patients undergoing modified radical mastectomy for breast cancer.

Study Type

Interventional

Enrollment (Estimated)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Recruiting
        • Nanjing First Hospital
        • Contact:
        • Contact:
        • Contact:
          • wang xiao liang, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Esketamine 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.
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.
Other: Normal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of PSD on postoperative day -1
Time Frame: the first day after surgery
On the first day after surgery, NRS ≥ 6 or AIS ≥ 6.PSD is defined as a numeric rating scale (NRS) ≥6 or Athens Insomnia Scale (AIS) ≥6, indicating that sleep is repeatedly disturbed or worse throughout the night. NRS scores range from 0 to 10, with 0 representing excellent or good sleep and 10 representing inability to sleep all night. AIS consists of 8 items: nighttime awakenings, sleep induction, final awakening, total sleep time, sleep quality, well-being, functional ability, and daytime sleepiness.
the first day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
static Visual Analog Scale score on postoperative day -2
Time Frame: on postoperative day -2
The painful visual simulation table of pain is a tool for evaluating the strength of pain. It is usually composed of a 10 -centimeter straight line. The two ends are marked as "painless" and "most pain". Patients are marked on the straight line according to their degree of pain.
on postoperative day -2
dynamic Visual Analog Scale score on postoperative day -2
Time Frame: on postoperative day -2
The painful visual simulation table of pain is a tool for evaluating the strength of pain. It is usually composed of a 10 -centimeter straight line. The two ends are marked as "painless" and "most pain". Patients are marked on the straight line according to their degree of pain.
on postoperative day -2
anxiety and depression score on the day before surgery
Time Frame: the day before surgery
The hosp Anxiety and depression scale is a self-evaluation table commonly used in evaluation of anxiety and depression . It contains 14 problems, divided into two sub-meters, and each sub-meter contains 7 items: Anxious sub -meter: Evaluate the anxiety experience of patients in the past week. Depression Meter: Evaluate the depression experience of patients in the past week. Each problem has four levels of options, corresponding to different scores, usually 0 to 3 points. The scoring standard is as follows: 0-7 points: normal 8-10 points: may be mild depression/anxiety
the day before surgery
The incidence of PSD on postoperative day -3
Time Frame: he third day after surgery
On the third day after surgery, NRS ≥ 6 or AIS ≥6.
he third day after surgery
The incidence of PSD on postoperative day -5
Time Frame: On the fifth day after surgery
On the fifth day after surgery, NRS ≥ 6 or AIS ≥6.
On the fifth day after surgery
The incidence of PSD on postoperative day 7
Time Frame: On the seventh day after surgery
On the seventh day after surgery, NRS ≥ 6 or AIS ≥6.
On the seventh day after surgery
static Visual Analog Scale score on postoperative day -1
Time Frame: on postoperative day -1
The painful visual simulation table of pain is a tool for evaluating the strength of pain. It is usually composed of a 10 -centimeter straight line. The two ends are marked as "painless" and "most pain". Patients are marked on the straight line according to their degree of pain.
on postoperative day -1
dynamic Visual Analog Scale score on postoperative day -1
Time Frame: on postoperative day -1
The painful visual simulation table of pain is a tool for evaluating the strength of pain. It is usually composed of a 10 -centimeter straight line. The two ends are marked as "painless" and "most pain". Patients are marked on the straight line according to their degree of pain.
on postoperative day -1
BDNF on postoperative day -1
Time Frame: on postoperative day -1
on postoperative day -1
TNFα on postoperative day -1
Time Frame: on postoperative day -1
on postoperative day -1
IL-6 on postoperative day -1
Time Frame: on postoperative day -1
on postoperative day -1

Other Outcome Measures

Outcome Measure
Time Frame
IL-6 blood on the day before surgery
Time Frame: the day before surgery
the day before surgery
TNFα on the day before surgery
Time Frame: the day before surgery
the day before surgery
BDNF on the day before surgery
Time Frame: the day before surgery
the day before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Investigators

  • Study Director: Xiaoliang Wang, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20240514-05-KS-01
  • ZKX21038 (Other Identifier: Nanjing Municipal Health Commission)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the relevant regulations of our hospital and considering the personal privacy of patients, we will not provide IPD. However, if necessary, you can also contact the researcher in charge of this study to view the relevant data to prove the authenticity of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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