Prophylactic esketamine to reduce postpartum depression in primiparae: A multicentre, double-blind, randomised clinical trial.

IF 7.8 2区医学 Q1 ANESTHESIOLOGY

European Journal of Anaesthesiology Pub Date : 2026-07-01 Epub Date: 2026-01-28 DOI:10.1097/EJA.0000000000002348

Tiantian Chu, Xiaoling Peng, Keliang Wan, Meihong Li, Tianzhu Liu, Xue Shi, Wenlong Yao, Shiyong Li, Zhiqiang Zhou, Changming Yang, Heng Xu, Jingjing Kong, Chan Wang, Jing Cheng, Zhenzhen Xu, Dezhan Li, Xin Liu, Junmin He, Xihong Ye, Ailin Luo, Aijun Xu, Feng Gao

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引用次数: 0

Abstract

Background: Postpartum depression (PPD) is a common complication after childbirth, especially in primiparae.

Objectives: This trial sought to evaluate whether prophylactic administration of esketamine during the perinatal period could prevent PPD in primiparae without predisposition to prenatal depression.

Design: A prospective, double-blind, multicentre, randomised controlled trial.

Setting: Three academic hospitals.

Patients: Primiparae scheduled for elective caesarean section with an Edinburgh Postnatal Depression Scale (EPDS) score less than 10.

Interventions: Postnatal women were randomly assigned to receive either i.v. esketamine in a single dose of 0.25 mg kg -1 followed by 80 mg of esketamine as an adjunct to 24-h patient-controlled intravenous analgesia (PCIA). Women in the control group received an equal volume of saline.

Main outcome measures: The primary outcome was the total incidence of PPD within 3 months postpartum. Secondary outcomes included postoperative EPDS scores, numeric rating scale scores, sufentanil consumption, the number of effective presses for postoperative intravenous analgesia and adverse events.

Results: A total of 322 patients were included in the modified intention-to-treat analysis. The total incidence of PPD in the esketamine group (11.59%) was significantly less than the control group (20.89%) [adjusted relative ratio (RR), 0.57; 95% CI, 0.35 to 0.94; P = 0.028] as was the incidence at 7 days postpartum (4.89 vs. 15.19%; adjusted RR, 0.32; 95% CI, 0.15 to 0.72; P = 0.005). However, there were no significant differences in PPD incidence and EPDS scores at 1, 2 and 3 months postpartum, respectively. Several mild central nervous events, such as dizziness (10.98%), hallucination (10.37%) and dissociation (5.49%), were observed during esketamine treatment.

Conclusion: Peri-operative adjunctive administration of esketamine is relatively safe and can prevent PPD in primi-parae without predisposition to prenatal depression in the short term.

Trial registration: Clinicaltrials.gov. Identifier: NCT04860661.

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预防性艾氯胺酮减少初产妇产后抑郁：一项多中心、双盲、随机临床试验

背景：产后抑郁（PPD）是分娩后常见的并发症，尤其是初产妇。目的：本试验旨在评估围产期预防性服用艾氯胺酮是否可以预防初产妇PPD，而不会导致产前抑郁。设计：前瞻性、双盲、多中心、随机对照试验。环境：三所学术医院。患者：爱丁堡产后抑郁量表（EPDS）评分低于10分，计划择期剖宫产的初产妇。干预措施：产后妇女被随机分配接受单剂量0.25 mg kg -1静脉注射艾氯胺酮，随后接受80 mg艾氯胺酮作为24小时患者控制静脉镇痛（PCIA）的辅助。对照组的女性接受等量的生理盐水。主要观察指标：主要观察指标为产后3个月内PPD总发生率。次要结局包括术后EPDS评分、数值评定量表评分、舒芬太尼用量、术后静脉镇痛有效按压次数和不良事件。结果：共有322例患者被纳入改良意向治疗分析。艾氯胺酮组PPD总发生率（11.59%）显著低于对照组（20.89%）[校正相对比（RR）， 0.57；95% CI, 0.35 ~ 0.94；P = 0.028]，产后7天的发生率（4.89比15.19%；调整后RR为0.32；95% CI为0.15 ~ 0.72;P = 0.005）。然而，产后1个月、2个月和3个月PPD发生率和EPDS评分差异无统计学意义。艾氯胺酮治疗期间出现头晕（10.98%）、幻觉（10.37%）和精神分离（5.49%）等轻度中枢神经事件。结论：围手术期辅助应用艾氯胺酮是相对安全的，可预防初产妇PPD，短期内无产前抑郁倾向。试验注册：Clinicaltrials.gov。标识符:NCT04860661。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

European Journal of Anaesthesiology 医学-麻醉学

CiteScore

6.90

自引率

11.10%

发文量

351

审稿时长

6-12 weeks

期刊介绍： The European Journal of Anaesthesiology (EJA) publishes original work of high scientific quality in the field of anaesthesiology, pain, emergency medicine and intensive care. Preference is given to experimental work or clinical observation in man, and to laboratory work of clinical relevance. The journal also publishes commissioned reviews by an authority, editorials, invited commentaries, special articles, pro and con debates, and short reports (correspondences, case reports, short reports of clinical studies).