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Evaluation of small-dose esketamine at ERa level for prevention of perinatal perinatal in women with failed trial of labor safety and feasibility of SHS and PPD in women with failed trial of labor.

Evaluation of small-dose esketamine at ERa level for prevention of perinatal perinatal in women with failed trial of labor safety and feasibility of SHS and PPD in women with failed trial of labor.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099590
Enrollment
Unknown
Registered
2025-03-26
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Postpartum depression

Interventions

Experimental group:Esketamine is given during the procedure and for the first two days after surgery. After the fetus is delivered, esketamine 0.2mg/kg diluted is given and pumped, pumped at a constan
Control group:Normal saline was used, infusion at the same rate, and the postoperative analgesic pump was sufentanil 100 µg tropisetron 10 mg prepared into 100 ml, background dose 2 ml/h, a single add

Sponsors

Maternal and Child Health Hospital of Jiangxi Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years and less than 35 years; 2. Gestational age >=37 and less than 40 weeks; 3. ASA Class I-III; 4. Failure of transvaginal trial of labor; 5. Undergoing cesarean section under pseudo-neuraxial anesthesia; 6. Fasting for 6 hours and drinking for more than 2 hours before surgery; 7. No contraindications to neuraxial anesthesia (puncture site infection, coagulation dysfunction, etc.); 8. Plan to receive postoperative intravenous self-controlled analgesia.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in this study; 2. Preoperative epilepsy, Parkinson's disease, myasthenia gravis, intracranial hypertension, delirium, schizophrenia or other psychiatric diseases; 3. Inability to communicate due to coma, severe dementia or language impairment before surgery; 4. Severe uncontrolled hypertension before surgery (basal blood pressure SBP>180 mmHg or DBP>110 mmHg in the ward); 5. History of hyperthyroidism and pheochromocytoma before surgery; 6. Patients with severe abnormal liver function (Child-Pugh grade C), severe renal function abnormalities (receiving dialysis before surgery) or expected to survive for = 24 hours; 7. Acute cardiovascular events within 30 days prior to surgery; 8. Planning for organ transplantation, vascular surgery, neurosurgery, etc.; 9. Have been treated with ketamine or esketamine; 10. Those who are allergic to ketamine or esketamine or have contraindications to use; 11. Other situations that the investigator or the doctor in charge deem inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
Incidence of postpartum depression;

Secondary

MeasureTime frame
Edinburgh Postnatal Depression Score;Numeric rating scale scores;Neuropsychiatric symptoms (e.g., nystagmus, dizziness, headaches, nightmares and hallucinations);Nausea and vomiting;Recovery of postoperative gastrointestinal function (time to first gas and bowel movement);Preoperative and 3d postoperative maternal CRP, IL6, IL8, TNF-a values;

Countries

China

Contacts

Public ContactLi Huanhuan

Jiangxi Maternal and Child Health Hospital

446019174@qq.com+86 159 7904 8151

Outcome results

None listed

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