Study of Low-Dose Esketamine Infusion During Breast Cancer Surgery to Improve Sleep Quality

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 mgkgh 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.

Effect of Subanesthetic Dose of Esketamine on Sleep Quality