Esketamine on Postpartum Depression in Cesarean Section Women

Study Overview
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Brief Summary
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This study was to explore the preventive effect of esketamine on postpartum depression in cesarean section, and to evaluate the safety of the drug

Detailed Description
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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.

Official Title
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Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study

Conditions
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Esketamine, Postpartum Depression

Intervention / Treatment
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* Drug: Esketamine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective cesarean section; 18-40 years; Primipara; Singleton pregnancy; Sign informed consent. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The incidence of PPD: the EPDS scale was assessed by face-to-face or telephone interview of the Puerpera 24 h, 7 d, 30 d, 60 d and 90 d after delivery. EPDS score ≥ 10 was defined as antenatal depression or postpartum emotional disorder.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: N group<br>15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline | Drug: Normal saline<br>* 10 ml normal saline<br>* Other names: Ns group;|
| Experimental: Es group<br>15 minutes after umbilical cord amputation, the patient was intravenously injected with 0.25mg/kg esketamine, PCIA regimen: sufentanil 100 μ g, esketamine 80 mg, diluted to 100 ml with 0.9% normal saline, set analgesia pump background infusion dose 2 ml/h, single bolus dose 2 ml, locking time 8 minutes. | Drug: Esketamine<br>* After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump<br>* Other names: Es group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edinburgh Postnatal Depression Scale(EPDS） scores | EPDS score is 0-30，and ≥ 10 to indicate depression | up to 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale/Score (VAS) score | VAS score is 0-100，and ≥ 30 to indicate the pain needs treatment | 1 Day before operation | 
| total number of PCA compressions | the total number of PCA compressions which the patients pressed | up to 24 hours after operation | 
| total volume of PCA | the total volume of PCA drugs which the patients needed in 24h after sugery | up to 24 hours after operation |