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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 april 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

160

Fas

  • Inte tillämpbar

Kontakter och platser

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Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

    -

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: 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
Läkemedel: Normal Saline (0.9% NaCl)
The same volume of normal saline was injected after fetal delivery during the operation
Aktiv komparator: 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
Läkemedel: Esketamine 0.3mg/kg
Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
NRS pruritus score at 24 hours after surgery
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
5-D itch scale at 72 hours after surgery
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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）
Tidsram: Perioperative period
Perioperative period
Intraoperative average heart rate（times per minute）
Tidsram: Perioperative period
Perioperative period
Intraoperative average blood oxygen saturation（%）
Tidsram: Perioperative period
Perioperative period
Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)
Tidsram: Perioperative period
Perioperative period
Adverse event
Tidsram: 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

Samarbetspartners och utredare

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Sponsor

Tianjin Medical University General Hospital

Utredare

  • Studierektor: Guolin Wang, Tianjin Medical University General Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

5 maj 2026

Primärt slutförande (Beräknad)

5 maj 2027

Avslutad studie (Beräknad)

11 augusti 2027

Studieregistreringsdatum

Först inskickad

10 april 2026

Först inskickad som uppfyllde QC-kriterierna

23 april 2026

Första postat (Faktisk)

1 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IRB2026-YX-129-01

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