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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorTianjin Medical University General Hospital

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Normal Saline (0.9% NaCl)
  • Esketamine 0.3mg/kg

Treatment groups

160 Participants
are divided into 2 treatment groups