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

23. dubna 2026 aktualizováno: Guolin Wang, Tianjin Medical University General Hospital

The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy:A Single-center Randomized Controlled 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

Intrahepatic cholestasis of pregnancy (ICP) is an important obstetric complication that occurs in the middle and late stages of pregnancy, characterized mainly by pruritus and elevated serum total bile acid (TBA) levels.

Pruritus usually begins on the palms and soles of the feet and can gradually spread. It typically shows a 'lighter during the day and heavier at night' pattern, severely affecting the patient's quality of life. It can also lead to physical and psychological disorders, and even cause mental abnormalities and self-harming behaviors in patients.

Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief, rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an important role in the transmission of non-histaminergic itching. Eslicarbazepine acetate, as a highly selective NMDA receptor antagonist, may alleviate the transmission and propagation of itching. However, there are no reports on whether a single intravenous injection of esketamine can alleviate the pruritus symptoms of patients with pregnancy-induced intrahepatic cholestasis. This experiment aims to investigate the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with pregnancy-induced intrahepatic cholestasis.

Typ studie

Intervenční

Zápis (Odhadovaný)

160

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Čína
      • Tianjin, Čína, 300052
        • Tianjin Medical University General Hospital
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  1. Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.
  2. Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.
  3. 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.
  4. Reporting pruritus NRS ≥ 4 points twice within one week.
  5. Planned to undergo cesarean section under intraspinal anesthesia.
  6. ASA classification: I - III grade.

Exclusion Criteria:

  1. Those who are known to be allergic to the drug components or have an allergic constitution.
  2. 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.
  3. Those with severe organic diseases and liver diseases.
  4. Those with malignant tumors.
  5. 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.
  6. Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies.
  7. ASA classification as grade IV.
  8. Those with poor compliance and unable to complete the trial according to the research protocol.
  9. Those who have participated in other drug clinical trials within the past 4 weeks.

  10. Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion.

    -

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: Placebo group of parturients with ICP and pruritus received normal saline
The equal volume of normal saline was injected intravenously after fetal delivery during the operation
Lék: Normal Saline (0.9% NaCl)
The same volume of normal saline was injected after fetal delivery during the operation
Aktivní komparátor: Group of parturients with ICP and pruritus received esketamine 0.3mg/kg
Esketamine 0.3mg/kg was injected intravenously after fetal delivery during the operation
Lék: Esketamine 0.3mg/kg
Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
NRS pruritus score at 24 hours after surgery
Časové okno: 24 hours after the 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
5-D itch scale at 72 hours after surgery
Časové okno: 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.
72 hours after surgery
NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery
Časové okno: 6 hours、12 hours、48 hours、72 hours 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.
6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
The incidence of pruritus on the 24 hours after surgery
Časové okno: 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.
24 hours after surgery
Total bile acid at 24 hours after surgery
Časové okno: 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.
24 hours after surgery
Pain Score (NRS)
Časové okno: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
The incidence of postoperative sleep disturbance on the first、second and third postoperative nights
Časové okno: the first、second and third nights after surgery
The patient completed the Sleep Quality Scale (AIS，Athens Insomnia Scale) one day before the surgery. There are a total of 8 items in the AIS, with the score ranging from 0 to 24. A total score of 6 or above indicates a diagnosis of insomnia. We asked the patients to fill out this questionnaire after the first, second and third postoperative nights to evaluate the changes in sleep quality. The investigators recorded AIS scores as statistical indicators.
the first、second and third nights after surgery
Postoperative anxiety
Časové okno: 72 hours after the surgery
The patient completed the Self-Rating Anxiety Scale (SAS, Self-Rating Anxiety Scale) one day before the surgery. The SAS consists of 20 items. Among them, 15 items are positive ratings (such as "I feel more nervous and anxious than usual"), and 5 items are negative ratings (such as "I feel everything is fine", which are the reverse items numbered 5, 9, 13, 17, and 19). The content covers subjective feelings of anxiety and various physical symptoms. The investigators asked the patient to fill out this questionnaire again 72 hours after the surgery to assess the changes in anxiety.
72 hours after the surgery
Postoperative depression
Časové okno: 72 hours after the surgery
The patient completed the Edinburgh Depression Scale (EPDS) one day before the surgery. The EPDS consists of 10 items, covering aspects such as mood, anxiety, and self-blame. Scores range from 0 to 9: within the normal range, no special intervention is required; 10-12: borderline range, suggesting a need for follow-up observation; 13-30: screening positive, indicating possible postpartum depression, and further assessment is necessary. The investigators asked the patient to fill out this questionnaire again at the seventy-second hour after the surgery to assess the changes in depression.
72 hours after the surgery
Key time points of the surgery
Časové okno: Perioperative period
  1. Duration of anesthesia （minutes）
  2. Duration of surgery （minutes）
  3. The time of fetal delivery（minutes）
Perioperative period
Intraoperative average blood pressure（mmHg）
Časové okno: Perioperative period
Perioperative period
Intraoperative average heart rate（times per minute）
Časové okno: Perioperative period
Perioperative period
Intraoperative average blood oxygen saturation（%）
Časové okno: Perioperative period
Perioperative period
Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)
Časové okno: Perioperative period
Perioperative period
Adverse event
Časové okno: Within 72 hours after the surgery
All kinds of adverse events( nausea, vomiting, headache，etc) occurred in patients were recorded.
Within 72 hours after the surgery

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Tianjin Medical University General Hospital

Vyšetřovatelé

  • Ředitel studie: Guolin Wang, Tianjin Medical University General Hospital

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

5. května 2026

Primární dokončení (Odhadovaný)

5. května 2027

Dokončení studie (Odhadovaný)

11. srpna 2027

Termíny zápisu do studia

První předloženo

10. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

23. dubna 2026

První zveřejněno (Aktuální)

1. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

1. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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