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Effect of low-dose esketamine on postpartum depression in women undergoing general anesthesia for cesarean delivery: a dual-center, prospective, randomized controlled study

Effect of low-dose esketamine on postpartum depression in women undergoing general anesthesia for cesarean delivery: a dual-center, prospective, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109671
Enrollment
Unknown
Registered
2025-09-23
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postpartum depression

Interventions

esketamine group:In the Esketamine (ESK) group, after fetal delivery:Esketamine at 0.2 mg/kg was added to 20 ml of normal saline and infused via pump over 40 minutes at a pump rate of 30 ml/h.At the e
Control:In the Control group, after fetal delivery: 20 ml normal saline was infused via pump over 40 minutes at a pump rate of 30 ml/h.At the end of surgery, patient-controlled intravenous analgesia (

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years old 2. American Society of Anesthesiologists (ASA) grade II to III; 3. Singleton pregnancy; 4. Term (>=37 weeks) pregnancy; 5. Planned elective cesarean section under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Prenatal mental disorders; 2. History of psychotropic drug use; 3. Severe obstetric comorbidities: such as preeclampsia and eclampsia, gestational hypertension, intracranial hypertension, hyperthyroidism, placenta previa or placental abruption, etc.; 4. Serious obstetric complications: such as intraoperative blood loss >1000 ml, combined organ damage (intestinal or urinary system injury), etc.; 5. Allergy to NMDA receptor antagonists; 6. Preoperative hypotension (defined as systolic blood pressure <90 mmHg); 7. Refusal to use postoperative analgesic pumps; Unwilling to cooperate with questionnaires and clinical examinations.

Design outcomes

Primary

MeasureTime frame
Incidence of postpartum depression;

Secondary

MeasureTime frame
Incidence of postnatal depression;Edinburgh Postnatal Depression Scale scores ;Pain intensity at rest and during activity ;Pain intensity ;Changes in vital signs (blood pressure, heart rate, and pulse oxygen saturation) before and after the esketamine or saline infusion were collected and compared;Neonatal variables were recorded, such as sex assigned at birth; body weight; Apgar score at 1, 5, and 10 minutes after delivery; and proportion of neonatal intensive care unit transfers;Time to first flatus after surgery, breastfeeding status, and length of hospital stay ;Length of postoperative hospital stay;Prenatal and postpartum Pittsburgh Sleep Quality Index (PSQI) scores;Antenatal EPDS scores;

Countries

China

Contacts

Public ContactCao Xiuhong

Shanghai First Maternity and Infant Hospital

caoxiuhong@51mch.com+86 139 1859 6527

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026