The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperati… (NCT07560722) | Clinical Trial Compass
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The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy
China160 participantsStarted 2026-05-05
Plain-language summary
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.
✓. Meet the diagnostic criteria of the "Clinical Diagnosis, Treatment and Management Guidelines for Intrahepatic Cholestasis of Pregnancy (2024 Edition)" : fasting serum TBA≥10 μmol/L or postprandial serum TBA≥19 μmol/L.
✓. Reporting pruritus NRS ≥ 4 points twice within one week.
✓. Planned to undergo cesarean section under intraspinal anesthesia.
✓. ASA classification: I - III grade.
Exclusion criteria
✕. Those who are known to be allergic to the drug components or have an allergic constitution.
✕. Related to the safe use of esketamine: history of mental illness; uncontrolled hypertension; uncontrolled hyperthyroidism; increased intracranial pressure, increased intraocular pressure; long-term alcohol consumption or drug abuse history.
✕. Those with severe organic diseases and liver diseases.
✕. Those with malignant tumors.
✕. Other pruritic diseases: uremic pruritus, true erythrocytosis, cutaneous T-cell lymphoma, eosinophilia, drug rash and drug-induced pruritus, and other pruritic diseases that are easily confused, such as atopic dermatitis, pemphigus, scabies, parasitic delusionism, artificial dermatitis, etc.
What they're measuring
1
NRS pruritus score at 24 hours after surgery
Timeframe: 24 hours after the surgery
Trial details
NCT IDNCT07560722
SponsorTianjin Medical University General Hospital