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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Normal Saline (0.9% NaCl)

    Drug

    The same volume of normal saline was injected after fetal delivery during the operation

  • Esketamine 0.3mg/kg

    Drug

    Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Placebo group of parturients with ICP and pruritus received normal salinePlacebo comparator 1 intervention
Group B: Group of parturients with ICP and pruritus received esketamine 0.3mg/kgActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

NRS pruritus score at 24 hours after surgery

The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.

Time frame
24 hours after the surgery

Secondary outcomes

1

5-D itch scale at 72 hours after surgery

The duration, severity, outcome trend, life impairment, and pruritus site (5-D) were used to evaluate the patient's pruritus. Each dimension was scored from 1 to 5, with a total score ranging from 5 to 25. The higher the score, the more severe the itching.

Time frame
72 hours after surgery
2

NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery

The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.

Time frame
6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
3

The incidence of pruritus on the 24 hours after surgery

The NRS pruritus score was completed by the patient 24 hours after the operation. The investigators recorded this score as a statistical indicator.

Time frame
24 hours after surgery
4

Total bile acid at 24 hours after surgery

The patient's fasting total bile acid level was checked the day before the operation. The investigators rechecked the fasting total bile acid levels 24 hours after the patient's surgery to assess the changes in total bile acid.

Time frame
24 hours after surgery

Other outcomes

Sponsors and contacts

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