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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Normal Saline (0.9% NaCl)
DrugThe same volume of normal saline was injected after fetal delivery during the operation
Esketamine 0.3mg/kg
DrugEsketamine 0.3mg/kg was given intravenously after fetal delivery during the operation
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: