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EKET: Esketamine on Postpartum Depression in Cesarean Section Women

Sponsor
Ailin Luo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04860661
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), Central South University (Other), The First Affiliated Hospital of Anhui Medical University (Other), The First Affiliated Hospital of University of South China (Other), Guangdong Women and Children Hospital (Other), Third Affiliated Hospital of Zhengzhou University (Other), First Affiliated Hospital of Guangxi Medical University (Other), Dalian Municipal Central Hospital (Other), Shandong Jining No.1 People's Hospital (Other), Maternal and Child Health Hospital of Hubei Province (Other)
1,248
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
62.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1248 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Assign a researcher to determine the order of patients and coordinate the relationship between researchers; For each patient, an anesthesiologist was assigned to manage anesthesia and collect intraoperative data; 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.
Primary Purpose:
Prevention
Official Title:
Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: N group

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

Drug: Normal saline
10 ml normal saline
Other Names:
  • Ns group

    		•
    Experimental: 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.

    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
    Other Names:
  • Es group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Edinburgh Postnatal Depression Scale(EPDS） scores [up to 90 days after surgery]

      EPDS score is 0-30，and ≥ 10 to indicate depression

    Secondary Outcome Measures

    1. Visual Analogue Scale/Score (VAS) score [1 Day before operation]

      VAS score is 0-100，and ≥ 30 to indicate the pain needs treatment

    2. total number of PCA compressions [up to 24 hours after operation]

      the total number of PCA compressions which the patients pressed

    3. total volume of PCA [up to 24 hours after operation]

      the total volume of PCA drugs which the patients needed in 24h after sugery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tongji Hospital Wuhan Hubei China 430000

    Sponsors and Collaborators

    • Ailin Luo
    • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    • Central South University
    • The First Affiliated Hospital of Anhui Medical University
    • The First Affiliated Hospital of University of South China
    • Guangdong Women and Children Hospital
    • Third Affiliated Hospital of Zhengzhou University
    • First Affiliated Hospital of Guangxi Medical University
    • Dalian Municipal Central Hospital
    • Shandong Jining No.1 People's Hospital
    • Maternal and Child Health Hospital of Hubei Province

    Investigators

    • Principal Investigator: Ailin luo, Dr., Department of Anesthesiology of Tongji Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ailin Luo, Professor, Tongji Hospital
    ClinicalTrials.gov Identifier:
    NCT04860661
    Other Study ID Numbers:
    • EKET
    First Posted:
    Apr 27, 2021
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression, Postpartum
    Depression
    Depressive Disorder
    Esketamine

    Study Results

    No Results Posted as of Apr 7, 2022