Clinical trial
Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study
Name
EKET
Description
This study was to explore the preventive effect of esketamine on postpartum depression in cesarean section, and to evaluate the safety of the drug
Trial arms
Trial start
2021-05-01
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Treatment
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
Arms:
Es group
Other names:
Es group
Normal saline
10 ml normal saline
Arms:
N group
Other names:
Ns group
Size
1248
Primary endpoint
Edinburgh Postnatal Depression Scale(EPDS） scores
up to 90 days after surgery
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': '1. Assign a researcher to determine the order of patients and coordinate the relationship between researchers;\n2. For each patient, an anesthesiologist was assigned to manage anesthesia and collect intraoperative data;\n3. 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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1248, 'type': 'ESTIMATED'}}
Updated at
2023-07-05
1 organization
1 product
1 drug
2 indications
Organization
Ailin LuoProduct
EsketamineIndication
EsketamineIndication
Postpartum DepressionDrug
Varlilumab