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Esketamine pretreatment during cesarean section reduced the incidence of PPD: A randomized controlled trail

Shixia Xu, Jiaojiao Yang, Jing Li, Min Zhang, Jie Sun, Qingren Liu, Jianjun Yang

preprint DOI: 10.21203/rs.3.rs-3482662/v1 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial
Sample size 319
Population Parturients undergoing cesarean delivery
Interventions Esketamine Saline
Dose 0.2 mg/kg
Duration 40-minute infusion; follow-up at 4 days and 42 days after surgery
Measures Amsterdam Anxiety and Information Scale (APAIS), Edinburgh postnatal depression scale (EPDS), Pain Numerical Rating Scale (NRS)
Topics Esketamine Ketamine
Key findings Intraoperative esketamine (0.2 mg/kg) reduced the incidence of postpartum depression at 4 days after cesarean delivery (13.8% vs 23.1%) but not at 42 days, and lowered pain scores at 6, 12, and 24 hours, while increasing maternal side effects such as dizziness, blurred vision, illusion, and drowsiness.

Abstract

Abstract Background Postpartum depression (PPD) is a common mental disease in postpartum women, which has received more and more attention in society. Ketamine has been confirmed for its rapid antidepressant effect in women with PPD. We speculate that esketamine, an enantiomer of ketamine, pretreatment during cesarean can also reduce the incidence of PPD.

Methods: All the parturients enrolled in the study were randomly assigned to two groups: the esktamine group (0.2 mg/kg esketamine) and the control group (a same volume of saline). All the drugs were pumped for 40 min started from the beginning of the surgery. The Amsterdam Anxiety and Information Scale (APAIS) scores before the surgery, the Edinburgh postnatal depression scale (EPDS) scores at 4 d and 42 d after surgery, the Pain Numerical Rating Scale (NRS) scores at 6 h, 12 h, 24 h and 48 h post-operation were evaluated, as well as the adverse reactions were recorded.

Results: A total of 319 parturients were analyzed in the study. The incidence rate of PPD (EPDS score > 9) in the esketamine group was decreased than the control group at 4 days after surgery (13.8% vs 23.1%, P = 0.0430 ) but not 42 days after surgery (P = 0.0987). Esketamine 0.2 mg/kg could reduce the NRS score at 6 h,12 h and 24 h after surgery, as well as the use of vasoactive drugs during surgery (P < 0.05). The incidences of maternal dizziness (17.0%), blurred vision (5%), illusion (3.8%) and drowsiness (3.8%) in the esketamine group were higher than those of control group (P < 0.05).

Conclusions: Intraoperative injection of esketamine (0.2 mg/kg) prevented the occurrence of depression (EPDS score > 9) at 4 days after delivery but not 42 days. Esketamine reduced the NRS scores at 6 h, 12 h and 24 h after surgery, but the occurrence of maternal side effects such as dizziness, blurred vision, drowsiness and hallucination were increased.

Trial Registration: Registered in the Chinese Clinical Trial Registry (ChiCTR2100053422) on 20/11/2021.

Comparable studies

Other randomized controlled trials on esketamine, most cited first.

Study Year Design Participants
Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study Adults with moderate to severe nonpsychotic depression and a history of nonresponse to... 2019 Phase 3, double-blind, active-controlled, multicenter randomized controlled trial n = 227
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression Adults with treatment-resistant depression who achieved stable remission or stable... 2019 Phase 3, multicenter, double-blind, randomized withdrawal study n = 297
Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression Adults with DSM-IV-TR diagnosis of major depressive disorder and history of inadequate... 2017 Phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study n = 67
Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study Depressed patients at imminent risk for suicide 2018 Randomized controlled trial n = 68
Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) Adults with moderate-to-severe depression and nonresponse to at least two... 2019 Randomized controlled trial n = 346

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