The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoin… (NCT07760740) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery
China100 participantsStarted 2026-08-15
Plain-language summary
To explore the effect of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Known allergy to any component of the study drug or history of allergic constitution;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NRS scores for pruritus assessed in the morning and evening on postoperative day 1
Timeframe: The morning and evening of the first day after the operation
Trial details
NCT IDNCT07760740
SponsorTianjin Medical University General Hospital
. 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;