Esketamine on Postpartum Depression in Cesarean Section Women

Not Applicable

Completed

• Conditions: Esketamine; Postpartum Depression
• Interventions: Drug: Normal saline; Drug: Esketamine

• Registration Number: NCT04860661
• Lead Sponsor: Ailin Luo

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

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 Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-25
• Study First Posted: 2021-04-27
• Study Start: 2021-05-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-03-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-04
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 336

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N group	Normal saline	15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline
Es group	Esketamine	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
total number of patient-controlled analgesia (PCA) compressions	up to 24 hours after operation	the total number of PCA compressions which the patients pressed
Numeric Rating Scale (NRS) score	1 Day before operation	NRS score is 0-10，and ≥ 4 to indicate the pain needs treatment
total volume of PCA	up to 24 hours after operation	the total volume of PCA drugs which the patients needed in 24h after surgery

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China