Esketamine on Postpartum Depression in Cesarean Section Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2024-03-31

Brief Summary

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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

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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.

Conditions

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Esketamine Postpartum Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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N group

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

10 ml normal saline

Es group

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.

Group Type EXPERIMENTAL

Esketamine

Intervention Type DRUG

After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump

Interventions

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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

Intervention Type DRUG

Normal saline

10 ml normal saline

Intervention Type DRUG

Other Intervention Names

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Es group Ns group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No