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

NCT07560722 | Not Yet Recruiting

• 1 other identifier: IRB2026-YX-129-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intrahepatic Cholestasis of Pregnancy

Keywords

esketamine; pruritus

Outcome Measures

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.

  24 hours after the surgery

Secondary Outcomes (14)

• 5-D itch scale at 72 hours after surgery

  72 hours after surgery

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

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

• The incidence of pruritus on the 24 hours after surgery

  24 hours after surgery

• Total bile acid at 24 hours after surgery

  24 hours after surgery

• Pain Score (NRS)

  6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery

Study Arms (2)

Placebo group of parturients with ICP and pruritus received normal saline

PLACEBO COMPARATOR

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

Drug: Normal Saline (0.9% NaCl)

Group of parturients with ICP and pruritus received esketamine 0.3mg/kg

ACTIVE COMPARATOR

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

Drug: Esketamine 0.3mg/kg

Interventions

Normal Saline (0.9% NaCl) DRUG

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

Placebo group of parturients with ICP and pruritus received normal saline

Esketamine 0.3mg/kg DRUG

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

Group of parturients with ICP and pruritus received esketamine 0.3mg/kg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Pruritus

Interventions

Saline Solution; Esketamine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Guolin Wang

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Guolin Wang

CONTACT

+8615822855556; wangguolinghad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: May 1, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): August 11, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)