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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 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

160

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
      • Tianjin, Chine, 300052
        • Tianjin Medical University General Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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.

    -

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur placebo: 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
Médicament: Normal Saline (0.9% NaCl)
The same volume of normal saline was injected after fetal delivery during the operation
Comparateur actif: 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
Médicament: Esketamine 0.3mg/kg
Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
NRS pruritus score at 24 hours after surgery
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
5-D itch scale at 72 hours after surgery
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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）
Délai: Perioperative period
Perioperative period
Intraoperative average heart rate（times per minute）
Délai: Perioperative period
Perioperative period
Intraoperative average blood oxygen saturation（%）
Délai: Perioperative period
Perioperative period
Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)
Délai: Perioperative period
Perioperative period
Adverse event
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Tianjin Medical University General Hospital

Les enquêteurs

  • Directeur d'études: Guolin Wang, Tianjin Medical University General Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

5 mai 2026

Achèvement primaire (Estimé)

5 mai 2027

Achèvement de l'étude (Estimé)

11 août 2027

Dates d'inscription aux études

Première soumission

10 avril 2026

Première soumission répondant aux critères de contrôle qualité

23 avril 2026

Première publication (Réel)

1 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IRB2026-YX-129-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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