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S-ketamine as an adjuvant in patient-controlled intravenous analgesia for preventing postpartum depression: a randomized controlled trial

Yaqian Han, Pule Li, Mengrong Miao, Yuan Tao, X. Kang, Jiaqiang Zhang

BMC Anesthesiology December 16, 2021 DOI: 10.1186/s12871-022-01588-7 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Randomized controlled trial Peer reviewed
Sample size 275
Population Parturients undergoing cesarean section and receiving patient-controlled intravenous analgesia
Interventions S-ketamine Sufentanil Tropisetron
Dose S-ketamine 0.5 mg/kg (loading) and 0.01 mg/kg/h (infusion); sufentanil 2 μg/kg; tropisetron 10 mg
Duration Postoperative days 3, 14, and 28
Measures Edinburgh postnatal depression scale (EPDS), visual analog scale (VAS), Ramsay sedation scale (RSS)
Topics Depression Esketamine Ketamine
Key findings S-ketamine as an adjuvant in PCIA reduced the incidence of postpartum depression on postoperative days 3 and 14 (8.2% vs 17.6% and 9.8% vs 24.2%) and lowered pain scores within 48 hours, with no significant difference by day 28 and no increase in adverse events.

Abstract

Background: Postpartum depression (PPD) is a common complication of cesarean section. S-ketamine given intravenously during surgery can help prevent PPD. However, whether S-ketamine in patient-controlled intravenous analgesia (PCIA) can reduce the incidence of PPD is unknown. This study assessed the effect of S-ketamine as an adjuvant in PCIA for preventing PPD in women undergoing cesarean delivery.

Methods: A total of 375 parturients scheduled to undergo cesarean section and then receive PCIA were recruited from a single center and were randomly assigned to control (C) group (sufentanil 2 μg/kg + tropisetron 10 mg) or S-ketamine (S) group (S-ketamine 0.5 mg/kg + sufentanil 2 μg/kg + tropisetron 10 mg). The primary outcome was the incidence of PPD measured by the Edinburgh postnatal depression scale (EPDS) after surgery. The secondary outcomes were EPDS scores, visual analog scale (VAS) scores, Ramsay sedation scale (RSS) scores, and the rate of adverse events, including headache, nausea, dizziness, drowsiness, and vomit.

Results: A total of 275 puerperal women were included in the study. The rate of depression in parturient on postoperative days 3, 14, 28 in the C group and S group were 17.6 and 8.2% ( p < 0.05), 24.2 and 9.8% (p < 0.05), and 19.0 and 17.2% ( p = 0.76) respectively. EPDS scores in the C group and S group on postoperative days 3,14, and 28 were 7.65 ± 3.14 and 6.00 ± 2.47 (p < 0.05), 7.62 ± 3.14 and 6.38 ± 2.67 (p < 0.05), and 7.35 ± 3.17 and 6.90 ± 2.78 ( p = 0.15), respectively. The rate of adverse events in the C group and S group were headache 3.3 and 4.1% ( p = 0.755), nausea 5.9 and 8.2% ( p = 0.481), dizziness 9.2 and 12.3% ( p = 0.434), drowsiness 6.5 and 10.7%( p = 0.274), and vomit 5.9 and 5.7% ( p = 0.585).

Conclusions: S-ketamine (0.01 mg/kg/h) as an adjuvant in PCIA significantly reduces the incidence of PPD within 14 days and relieves pain within 48 h after cesarean delivery, without increasing the rate of adverse reactions. Trial registration Registered in the Chinese Clinical Trial Registry ( ChiCTR2100050263 ) on August 24, 2021.

Comparable studies

Other randomized controlled trials on esketamine for depression, 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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