Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID06773143

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

Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2025-02-10

184

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether low doses of esketamine can improve sleep quality in patients undergoing modified radical mastectomy for breast cancer after chemotherapy. This study focuses on managing postoperative sleep disturbances, which are common and can negatively affect recovery. The trial involves 184 female participants aged 18 to 65 who have breast cancer and are receiving neoadjuvant chemotherapy. Sleep disturbances after surgery can affect pain, inflammation, and overall recovery, and this study aims to explore whether esketamine can help reduce these problems. Participants will be randomly assigned to one of two groups. One group will receive a continuous infusion of esketamine (0.3 mg/kg/h) during their surgery after anesthesia induction, while the other group will receive a placebo infusion of normal saline. The infusion continues until the end of the operation. The study includes assessments before surgery, on the day after surgery, and three days after surgery to evaluate sleep quality, pain, anxiety, depression, and blood markers related to inflammation and brain function. Participants will complete several rating scales such as the Athens Insomnia Scale, Visual Analog Pain Rating Scale, and the Hospital Anxiety and Depression Scale at multiple time points. Blood samples will be collected to measure inflammatory and other biological markers. Researchers will monitor analgesic use and follow up on sleep disturbances three days after surgery. The main outcome measured is the incidence of postoperative sleep disturbance on the first day after surgery. Additional assessments will occur on other days to track pain, mood, and biological changes. The study will last from admission to three days post-surgery.

CONDITIONS

Brief 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...

  • Patients diagnosed with breast cancer by pathology and immunohistochemistry
  • Patients receiving neoadjuvant chemotherapy
  • Age 18 to 65 years old
  • ASA grade I to II
  • BMI between 18 and 30 kg/m2
Not Eligible

You will not qualify if you...

  • Patients who refuse to participate in the study
  • BMI greater than 30 kg/m2
  • Recent history of drug abuse
  • Allergy to or contraindications to esketamine
  • Cognitive dysfunction or inability to communicate
  • Severe dysfunction of important organs such as liver and kidney function

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo modified radical mastectomy for breast cancer. After induction of general anesthesia, participants receive a continuous infusion of either low-dose esketamine or normal saline until the end of the operation.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 7 days after surgery

Participants are monitored for postoperative sleep disturbances and recovery. Assessments include sleep quality, pain scores, anxiety and depression levels, and inflammatory markers on days following surgery.

Multiple visits on postoperative days 1, 2, 3, 5, and 7 (in-person)

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

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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Published Research Related To This Trial

Sleep improvement is associated with the antidepressant efficacy of repeated-dose ketamine and serum BDNF levels: a post-hoc analysis.

Mingqia Wang, Bin Zhang, Yangling Zhou...

https://pubmed.ncbi.nlm.nih.gov/33387333

Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site randomized controlled trial.

James W Murrough, Dan V Iosifescu, Lee C Chang...

https://pubmed.ncbi.nlm.nih.gov/23982301

Effect of Intraoperative Esketamine Infusion on Postoperative Sleep Disturbance After Gynecological Laparoscopy: A Randomized Clinical Trial.

Di Qiu, Xing-Ming Wang, Jin-Jin Yang...

https://pubmed.ncbi.nlm.nih.gov/36454569

Cognitive behavioral therapy for insomnia outcomes in women after primary breast cancer treatment: a randomized, controlled trial.

Ellyn E Matthews, Ann M Berger, Sarah J Schmiege...

https://pubmed.ncbi.nlm.nih.gov/24650832