Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

11 augustus 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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
Placebo-vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
NRS scores for pruritus assessed in the morning and evening on postoperative day 1
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The NRS scores for pruritus in the morning and evening on the second and third days after the operation.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: Within 72 hours postoperatively
  1. Nausea and vomiting
  2. Dizziness
  3. Nightmare
  4. Respiratory depression
  5. hallucinations
Within 72 hours postoperatively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 augustus 2026

Primaire voltooiing (Geschat)

20 april 2027

Studie voltooiing (Geschat)

20 april 2027

Studieregistratiedata

Eerst ingediend

14 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 augustus 2026

Eerst geplaatst (Werkelijk)

12 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

11 augustus 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • IRB2025-YX-497-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren