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Low-Dose Esketamine for Prevention of Postoperative Depression in Women and Partners After Pregnancy Loss Surgery: A Randomized Placebo-Controlled Trial

Effect of Low-Dose Esketamine on Postoperative Depressive Symptoms in Patients with Ectopic Pregnancy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114343
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-12-17
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Postoperative depression in patients undergoing gynecologic surgery

Interventions

Esketamine Group:Esketamine (0.2 mg/kg) was administered intravenously during anesthesia induction.
Placebo Group:An equal volume of normal saline was administered concomitantly in the control group.

Sponsors

Shijiazhuang Fourth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–45 years, BMI 18.5–28 kg/m²; 2. Diagnosed via ultrasound and clinical examination as: (1) Missed abortion / incomplete abortion (requiring curettage); (2) Ectopic pregnancy (primarily tubal, requiring laparoscopic or open surgery); 3. American Society of Anesthesiologists (ASA) physical status classification: Class I-II; 4. Voluntary signing of informed consent form, committing to complete all follow-up appointments.

Exclusion criteria

Exclusion criteria: 1. History of previous mental illnesses (e.g., depression, bipolar disorder, schizophrenia); 2. Allergy or contraindication to esketamine, propofol, sufentanil or related drugs; 3. Uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg), coronary heart disease, severe hepatic or renal insufficiency (ALT/AST > 3 times the upper limit of normal, Cr > 133 µmol/L), aneurysmal vascular disease, arteriovenous malformation, history of intracerebral hemorrhage, or recent cardiovascular events (e.g., myocardial infarction); 4. History of substance abuse (opioids, sedative-hypnotics) or alcohol dependence (>=14 standard drinks per week in the past 6 months); 5. Patients with untreated or inadequately treated hyperthyroidism; 6. Cognitive impairment or language communication disorders; 7. Participation in other clinical studies within the past 1 month.

Design outcomes

Primary

MeasureTime frame
EPDS score change value;

Secondary

MeasureTime frame
HAMD-17 Moderate-to-Severe Depression Incidence;Spouse PHQ-9 score;PSQI score;

Countries

China

Contacts

Public ContactXuefeng Cui

Shijiazhuang Fourth Hospital

15350596587@163.com+86 153 5059 6587

Outcome results

None listed

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