An interventional study of Esketamine and Normal saline in Esketamine and Postpartum Depression, sponsored by Ailin Luo. Completed at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Ailin Luo · Not applicable, Interventional, and Prevention
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
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 336 is above the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Ailin Luo is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline
Drug: Normal saline
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
After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump
Also known as: Es group
10 ml normal saline
Also known as: Ns group
Edinburgh Postnatal Depression Scale(EPDS） scores
EPDS score is 0-30，and ≥ 10 to indicate depression
Time frame: up to 90 days after surgery
Numeric Rating Scale (NRS) score
NRS score is 0-10，and ≥ 4 to indicate the pain needs treatment
Time frame: 1 Day before operation
total number of patient-controlled analgesia (PCA) compressions
the total number of PCA compressions which the patients pressed
Time frame: up to 24 hours after operation
total volume of PCA
the total volume of PCA drugs which the patients needed in 24h after surgery
Time frame: up to 24 hours after operation
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Ailin Luo