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The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery

11. srpna 2026 aktualizováno: Guolin Wang, Tianjin Medical University General Hospital

The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery: A Single-center Randomized Controlled Study

To explore the effect of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery

Přehled studie

Postavení

Zatím nenabíráme

Detailní popis

Cholestatic pruritus is a common and refractory symptom in patients undergoing hepatobiliary surgery, often caused by impaired bile excretion due to bile duct stones, biliary tumors, or bile duct strictures. Patients typically present with moderate to severe pruritus, initially or most severely affecting the palms and soles, which significantly impairs quality of life and is frequently accompanied by sleep disturbances, anxiety, and depression. Esketamine, as an NMDA receptor antagonist, exhibits anti-hyperalgesic effects and inhibits central sensitization. Recent studies suggest that it may also alleviate refractory pruritus. This study aims to investigate the effect of intraoperative continuous infusion of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery

Typ studie

Intervenční

Zápis (Odhadovaný)

100

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

      • Tianjin, Čína
        • Tianjin Medical University General Hospital, Tianjin, 300052
        • 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
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • 1. Inclusion Criteria:

    1. Patients with cholestasis caused by bile duct stones, gallbladder stones, bile duct strictures, pancreatic head cancer, cholangiocarcinoma, or periampullary carcinoma, etc.
    2. Manifestations of cholestatic pruritus, typically with the palms and soles as the initial or most severely affected sites, which may extend to the limbs and trunk; possibly accompanied by jaundice (yellowing of the skin and sclera), dark urine (e.g., tea-colored), and clay-colored stools; often with a tendency to worsen at night.
    3. Report of pruritus with an NRS score ≥ 4 (moderate to severe pruritus) twice within one week.
    4. Scheduled for elective hepatobiliary surgery under general anesthesia, including but not limited to: partial hepatectomy, common bile duct exploration, choledocholithotomy, biliary-enteric anastomosis (e.g., Roux-en-Y anastomosis), pancreaticoduodenectomy (Whipple procedure), and radical resection of hilar cholangiocarcinoma.
    5. American Society of Anesthesiologists (ASA) physical status classification I-III.
    6. Age ≥ 18 years, body mass index (BMI) between 18 and 30 kg/m², regardless of gender.
    7. Patients have fully understood the nature of the study, voluntarily agree to participate, and have signed the informed consent form.

Exclusion Criteria:

  1. Known allergy to any component of the study drug or history of allergic constitution;
  2. History of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
  3. History of neurological disease; history of chronic pain; substance abuse or alcoholism; long-term use of opioids; administration of opioids within 48 hours prior to surgery;
  4. ASA physical status classification IV;
  5. Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, renal dysfunction, or marked electrolyte abnormalities;
  6. History of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
  7. Respiratory insufficiency or respiratory failure;
  8. Preoperative diagnosis of severe liver failure of Child-Pugh class C or presence of hepatic encephalopathy;
  9. Other pruritic disorders: uremic pruritus, polycythemia vera, cutaneous T-cell lymphoma, hypereosinophilia, drug eruption and drug-induced pruritus, as well as other pruritic diseases that may be easily confused, such as atopic dermatitis, pemphigoid, scabies, delusional parasitosis, dermatitis artefacta, etc.;
  10. Pregnant or breastfeeding women;
  11. BMI < 18 kg/m² or BMI > 30 kg/m²;
  12. Poor compliance or inability to complete the study according to the protocol;
  13. Participation in another drug clinical trial within the past 4 weeks;
  14. Any other condition that, in the opinion of the investigators, makes the patient unsuitable for enrollment.

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: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: Patients receiving esketamine intervention
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation.
Continuous intraoperative infusion of esketamine at 0.3 mg/kg/h
Komparátor placeba: Patients receiving an equal volume of saline
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.
Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of an equal volume of normal saline during the operation as a placebo control.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
NRS scores for pruritus assessed in the morning and evening on postoperative day 1
Časové okno: The morning and evening of the first day after the operation
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 morning and evening of the first day after the operation

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The NRS scores for pruritus in the morning and evening on the second and third days after the operation.
Časové okno: On the morning and evening of the second and third days after the operation
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.
On the morning and evening of the second and third days after the operation
The incidence of sleep disorders on postoperative days 1-3
Časové okno: The first, second and third days after the surgery
Patients completed the sleep quality scale(AIS, Athens Insomnia Scale) on the first, second and third day after surgery. The AIS has a total of 8 items, with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia. The investigators 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 days after the surgery
Postoperative anxiety
Časové okno: 1 day before surgery ,1 -3 days after surgery
Patients completed the anxiety rating scales (HADS-A, Hospital Anxiety and Depression Scale-Anxiety subscale) on the day before surgery. HADS-A consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as anxiety. And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in anxiety. The investigators recorded HADS-A scores as statistical indicators
1 day before surgery ,1 -3 days after surgery
Postoperative depression
Časové okno: 1 day before surgery ,1 -3 days after surgery
Patients completed the depression rating scales (HADS-D, Hospital Anxiety and Depression Scale-Depression subscale) on the day before surgery. HADS-D consists of 7 items, each question in the questionnaire was scored on a scale of 0-3, and a total score of 8 points or higher is diagnosed as depression. And the investigators asked the patients to fill out this questionnaire on the 1-3 days after surgery again to evaluate the changes in depression. The investigators recorded HADS-D scores as statistical indicators.
1 day before surgery ,1 -3 days after surgery
Pain Score (NRS)
Časové okno: 1-3 days after 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.
1-3 days after surgery
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
Liver function tests (LFTs)
Časové okno: Preoperative baseline and postoperative day one
  1. Alanine Transaminase, ALT
  2. Aspartate Aminotransferase, AST
  3. Total Bilirubin, TBil
  4. Direct Bilirubin, DBIL
  5. Alkaline phosphatase, ALP
  6. Gamma-glutamyltransferase, GGT
Preoperative baseline and postoperative day one
Postoperative Complications
Časové okno: Within 72 hours postoperatively
  1. Nausea and vomiting
  2. Dizziness
  3. Nightmare
  4. Respiratory depression
  5. hallucinations
Within 72 hours postoperatively

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

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)

15. srpna 2026

Primární dokončení (Odhadovaný)

20. dubna 2027

Dokončení studie (Odhadovaný)

20. dubna 2027

Termíny zápisu do studia

První předloženo

14. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

11. srpna 2026

První zveřejněno (Aktuální)

12. srpna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. srpna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. srpna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • IRB2025-YX-497-01

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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