Esketamine on Postpartum Depression in Cesarean Section Women (EKET)

Ailin Luo

Status: Completed

Conditions: Esketamine; Postpartum Depression

Treatments: Drug: Esketamine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04860661

EKET

Details and patient eligibility

About

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

Full 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.

Enrollment: 336 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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336 participants in 2 patient groups, including a placebo group

N group

Placebo Comparator group

Description:

15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline

Treatment:

Drug: Normal saline

Es group

Experimental group

Description:

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.

Treatment:

Drug: Esketamine