The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy

Starting soon · Not applicable · Has a placebo group

Conditions studied: Intrahepatic Cholestasis of Pregnancy

In brief

To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.

Key facts

Study ID

NCT07560722

Run by

Tianjin Medical University General Hospital

People needed

160

Starts

2026-05-05

Expected to finish

2027-08-11

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.
• 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.

You may not qualify if…

• 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.
• Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies.
• ASA classification as grade IV.
• Those with poor compliance and unable to complete the trial according to the research protocol.
• Those who have participated in other drug clinical trials within the past 4 weeks.
• Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion.

Where it is running

• Tianjin Medical University General Hospital — Tianjin, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.