Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 336
- 试验地点
- 1
- 主要终点
- Edinburgh Postnatal Depression Scale(EPDS） scores
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
- 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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective cesarean section;
- •18-40 years;
- •Primipara;
- •Singleton pregnancy;
- •Sign informed consent.
排除标准
- •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.
研究组 & 干预措施
N group
15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline
干预措施: Normal saline (Drug)
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.
干预措施: Esketamine (Drug)
结局指标
主要结局
Edinburgh Postnatal Depression Scale(EPDS） scores
时间窗: up to 90 days after surgery
EPDS score is 0-30，and ≥ 10 to indicate depression
次要结局
- total number of patient-controlled analgesia (PCA) compressions(up to 24 hours after operation)
- Numeric Rating Scale (NRS) score(1 Day before operation)
- total volume of PCA(up to 24 hours after operation)
研究者
Ailin Luo
Professor
Tongji Hospital