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

NCT07760740 | Not Yet Recruiting

• 1 other identifier: IRB2025-YX-497-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholestatic Pruritus

Keywords

cholestatic pruritus; esketamine

Outcome Measures

Primary Outcomes (1)

• NRS scores for pruritus assessed in the morning and evening on postoperative day 1

  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

Secondary Outcomes (8)

• The NRS scores for pruritus in the morning and evening on the second and third days after the operation.

  On the morning and evening of the second and third days after the operation

• The incidence of sleep disorders on postoperative days 1-3

  The first, second and third days after the surgery

• Postoperative anxiety

  1 day before surgery ,1 -3 days after surgery

• Postoperative depression

  1 day before surgery ,1 -3 days after surgery

• Pain Score (NRS)

  1-3 days after surgery

Study Arms (2)

Patients receiving esketamine intervention

ACTIVE COMPARATOR

Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation.

Drug: Esketamine

Patients receiving an equal volume of saline

PLACEBO COMPARATOR

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.

Drug: normal Saline

Interventions

Esketamine DRUG

Continuous intraoperative infusion of esketamine at 0.3 mg/kg/h

Patients receiving esketamine intervention

normal Saline DRUG

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 receiving an equal volume of saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cholestasis caused by bile duct stones, gallbladder stones, bile duct strictures, pancreatic head cancer, cholangiocarcinoma, or periampullary carcinoma, etc.
• 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.
• Report of pruritus with an NRS score ≥ 4 (moderate to severe pruritus) twice within one week.
• 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.
• American Society of Anesthesiologists (ASA) physical status classification I-III.
• Age ≥ 18 years, body mass index (BMI) between 18 and 30 kg/m², regardless of gender.
• Patients have fully understood the nature of the study, voluntarily agree to participate, and have signed the informed consent form.

You may not qualify if:

• Known allergy to any component of the study drug or history of allergic constitution;
• History of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
• 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;
• ASA physical status classification IV;
• Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, renal dysfunction, or marked electrolyte abnormalities;
• History of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
• Respiratory insufficiency or respiratory failure;
• Preoperative diagnosis of severe liver failure of Child-Pugh class C or presence of hepatic encephalopathy;
• 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.;
• Pregnant or breastfeeding women;
• BMI \< 18 kg/m² or BMI \> 30 kg/m²;
• Poor compliance or inability to complete the study according to the protocol;
• Participation in another drug clinical trial within the past 4 weeks;
• Any other condition that, in the opinion of the investigators, makes the patient unsuitable for enrollment.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital, Tianjin, 300052

Tianjin, China

Location

MeSH Terms

Interventions

Esketamine; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Guolin Wang, Study Director

CONTACT

+8615822855556; wangguolinghad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)