Esketamine on Postpartum Depression in Cesarean Section Women

NCT04860661 | Completed

• 1 other identifier: EKET
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esketamine; Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• Edinburgh Postnatal Depression Scale(EPDS） scores

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

  up to 90 days after surgery

Secondary Outcomes (3)

• Numeric Rating Scale (NRS) score

  1 Day before operation

• total number of patient-controlled analgesia (PCA) compressions

  up to 24 hours after operation

• total volume of PCA

  up to 24 hours after operation

Study Arms (2)

N group

PLACEBO COMPARATOR

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

Drug: Normal saline

Es group

EXPERIMENTAL

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

Interventions

Esketamine 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

Also known as: Es group

Es group

Normal saline DRUG

10 ml normal saline

Also known as: Ns group

N group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: The objects of this observation were puerpera with cesarean section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Elective cesarean section;
• years;
• Primipara;
• Singleton pregnancy;
• Sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ailin Luo: lead
• Maternal and Child Health Hospital of Hubei Province: collaborator
• Jingmen No.1 People's Hospital: collaborator

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Related Publications (1)

• Chu T, Peng X, Wan K, Li M, Liu T, Shi X, Yao W, Li S, Zhou Z, Yang C, Xu H, Kong J, Wang C, Cheng J, Xu Z, Li D, Liu X, He J, Ye X, Luo A, Xu A, Gao F. Prophylactic esketamine to reduce postpartum depression in primiparae: A multicentre, double-blind, randomised clinical trial. Eur J Anaesthesiol. 2026 Jan 29. doi: 10.1097/EJA.0000000000002348. Online ahead of print.

  PMID: 41607308 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ailin luo, Dr.

  Department of Anesthesiology of Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 27, 2021
• Study Start: May 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)