Postoperative Depressive
Conditions
Interventions
Esketamine group:0.25 mg/kg esketamine is diluted to 20 mL and administered intravenously at a rate of 30 mL/h.
Placebo group:An equal volume of normal saline is administered intravenously at a rate of 30 mL/h.
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years; 2. Female patients; 3. ASA class I-III; 4. Mild-to-severe depressive symptoms(11 scores < MADRS < 35 scores); 5. Scheduled for the elective unilateral radical mastectomy for breast cancer; 6. Able to provide written, informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have contraindications or allergies to the use of esketamine; 2. Patients with preoperative radiotherapy or endocrine therapy and secondary surgery (recurrence or reconstruction); 3. BMI > 30 kg/m2; 4. History of psychosis, bipolar disorder, and recurrent depression; 5. History of antidepressant treatment within 2 weeks pre-screening; 6. Patients with preoperative severe functional abnormalities of the liver and kidneys; 7. Patients who are unable to cooperate with the study for any reason: such as hearing or visual impairment, language comprehension disorder, mental illness; 8. History of drug dependence or current pregnancy or breastfeeding; 9. Pre-operative planned ICU admission; 10. Persons who have already participated in other studies; 11. Contraindicated for MRI ( for example, claustrophobia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montgomery Depression Scale Scores;Postoperative depression severity;Remission rate;Incidence of severe postoperative pain;length of postoperative hospital stays; | — |
Countries
China
Contacts
Public ContactXuesheng Liu
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed