Breast cancer postoperative depression
Conditions
Interventions
Normal saline group:Intravenous administration of saline 0.2 mg/kg after induction of anesthesia and before skin incision
Esketamine group:Intravenous administration of esketamine 0.2 mg/kg after induction of anesthesia and before skin incision
Sponsors
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1:18-80 year old female; 2: Initial diagnosis of stage I-III breast cancer; 3: American Society of Anesthesiologists (ASA) grades I-III; 4: Proposed surgical treatment for breast cancer and the patient has not previously undergone surgical treatment for breast cancer(If the patient has only received previous treatment for benign breast diseases, such as fibrotomy, and the postoperative pathology confirms that there is no malignant lesion, they may be considered for inclusion in the study, but the relevant information of the previous treatment should be recorded in detail in the case report form); 5: Be able to understand the research objectives to support the follow-up process; 6: Voluntary participation in research and signing of informed consent.
Exclusion criteria
Exclusion criteria: 1: Previous history of other malignancies; 2: Have been treated for depression in the past two months or have a previous history of mental illness; 3: Pregnancy or lactation; 4: Allergic to ketamine or esketamine or presence of contraindications; 5: Other circumstances that the investigator does not consider appropriate for inclusion in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of depressive symptoms at 1 month postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of depressive symptoms before surgery and at 7 days, 3 months, 6 months postoperatively;Incidence of anxiety symptoms before surgery and at 7 days,1 month, 3 months, 6 months postoperatively;Incidence of acute pain within 48 hours after surgery;Incidence of chronic pain at month 3, 6 postoperatively;Effect of perioperative treatment (including preoperative neoadjuvant therapy, postoperative adjuvant therapy, surgical anesthesia operation, etc.) on postoperative depression, anxiety and pain;Incidence of adverse events, including nausea, vomiting, pruritus, and respiratory depression;Oncologic outcomes including overall survival and disease-free survival between groups; | — |
Countries
China
Contacts
Public ContactYan Tao
Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed