Esketamine, Postpartum Depression
Conditions
Brief summary
This study was to explore the preventive effect of esketamine on postpartum depression (PPD) in cesarean section, and to evaluate the safety of the drug
Detailed description
Studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. Esketamine has been approved by FDA for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? It is not clear. Based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug.
Interventions
DRUGEsketamine
After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump
DRUGNormal saline
10 ml normal saline
Sponsors
Maternal and Child Health Hospital of Hubei Province
Jingmen No.1 People's Hospital
Ailin Luo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
1. Assign a researcher to determine the order of patients and coordinate the relationship between researchers; 2. For each patient, an anesthesiologist was assigned to manage anesthesia and collect intraoperative data; 3. A researcher who was not aware of the protocol was assigned to conduct preoperative evaluation and postoperative follow-up, and received training on evaluation methods before the study.
Intervention model description
The incidence of PPD: the EPDS scale was assessed by face-to-face or telephone interview of the Puerpera 7 d, 30 d, 60 d and 90 d after delivery. EPDS score ≥ 10 was defined as antenatal depression or postpartum emotional disorder.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Elective cesarean section; * 18-40 years; * Primipara; * Singleton pregnancy; * Sign informed consent.
Exclusion criteria
* American Society of Anesthesiologists (ASA) grade III and above; * Intracranial hypertension; * Hypertension; * Severe heart disease; * Hyperthyroidism patients without treatment or insufficient treatment; * Liver and kidney dysfunction; * Preeclampsia or eclampsia; * Mental disorder, mental retardation; * Drug abuse and alcoholism; * Contraindication of intraspinal anesthesia; * The preoperative EPDS score ≥10; * Participated in other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edinburgh Postnatal Depression Scale(EPDS） scores | up to 90 days after surgery | EPDS score is 0-30，and ≥ 10 to indicate depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) score | 1 Day before operation | NRS score is 0-10，and ≥ 4 to indicate the pain needs treatment |
| total number of patient-controlled analgesia (PCA) compressions | up to 24 hours after operation | the total number of PCA compressions which the patients pressed |
| total volume of PCA | up to 24 hours after operation | the total volume of PCA drugs which the patients needed in 24h after surgery |
Countries
China
Outcome results
None listed