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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University General Hospital

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Esketamine
  • normal Saline

Treatment groups

100 Participants
are divided into 2 treatment groups