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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04860661
Other study ID # EKET
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date December 31, 2023

Study information

Verified date April 2023
Source Tongji Hospital
Contact Feng Gao, Dr.
Phone 86-27-83663173
Email fgao@tjh.tjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1248
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Intervention

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
Normal saline
10 ml normal saline

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (11)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Edinburgh Postnatal Depression Scale(EPDS) scores EPDS score is 0-30,and = 10 to indicate depression up to 90 days after surgery
Secondary Visual Analogue Scale/Score (VAS) score VAS score is 0-100,and = 30 to indicate the pain needs treatment 1 Day before operation
Secondary total number of PCA compressions the total number of PCA compressions which the patients pressed up to 24 hours after operation
Secondary total volume of PCA the total volume of PCA drugs which the patients needed in 24h after sugery up to 24 hours after operation
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