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Dose-effect relationship of esketamine for the prevention of postpartum depression in patients with caesarean section: a randomized, controlled, double-blind clinical trial

Dose-effect relationship of esketamine for the prevention of postpartum depression in patients with caesarean section: a randomized, controlled, double-blind clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085315
Enrollment
Unknown
Registered
2024-06-05
Start date
2024-06-07
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

postpartum depression

Interventions

study group:Injection of esketamine 0.15mg/kg(20ml)
study group:Injection of esketamine 0.2mg/kg(20ml)
study group:Injection of esketamine 0.3mg/kg(20ml)

Sponsors

The First Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 35 Years

Inclusion criteria

Inclusion criteria: ) age between 20 and 35; 2)ASAII grade, BMI18-30kg/m2; 3) Single-term pregnant women who are scheduled to undergo cesarean section under spinal anesthesia; 4) preoperative e Edinburgh score scale < 10; 5) Understand clearly and voluntarily participate in the study, and sign the informed consent form by himself.

Exclusion criteria

Exclusion criteria: 1) Have a history of mental illness or family history or are using other antidepressants; 2) communication and communication barriers; 3) Hyperthyroidism, hypertension, pregnancy-induced hypertension or eclampsia; 4) Contraindications to esketamine: such as allergy, increased intracranial pressure, increased intraocular pressure and increased intragastric pressure; 5) Have a history of abuse of psychotropic drugs and/or alcohol; 6) Patients with chronic pain and/or long-term oral painkillers; 7) Long-term oral glucocorticoid; 8) Complicated with serious heart, lung, liver and renal dysfunction; 9) Fetus with congenital diseases or malformations; 10) local anesthetic allergy;11) Contraindications for intraspinal anesthesia

Design outcomes

Primary

MeasureTime frame
Incidence of postpartum depression six weeks after operation;1, 2, 3 days of postoperative exercise and resting pain VAS score;

Secondary

MeasureTime frame
Edinburgh Postpartum Depression scale score at 1 week, 2 weeks, 4 weeks and 6 weeks after operation;Ramsay score of 5 minutes after drug injection, at the end of the operation, and 1 day after surgery;BPRS+ score of 5 minutes after drug injection, at the end of the operation, and 1 day after surgery;

Countries

China

Contacts

Public ContactWei Ke

The First Affiliated Hospital of Chongqing Medical University

Wk202448@hospital-cqmu.com+86 159 0236 0621

Outcome results

None listed

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