Could a surgical anesthetic calm unbearable Liver-Related itching?
NCT ID NCT07760740
First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time
Summary
This trial asks whether giving esketamine during surgery can reduce the intense itching caused by cholestasis, a condition where bile flow is blocked. About 100 patients undergoing hepatobiliary surgery will receive either esketamine or a placebo infusion. Researchers will track itching scores for the first three days after surgery to see if esketamine provides relief.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Esketamine, given as a continuous infusion during surgery
- What this could lead to
- If effective, esketamine could offer a new way to relieve severe itching in patients with cholestasis, improving comfort after surgery.
- What could go wrong
- This is a small, early-stage trial, and the effect on itching is uncertain. Esketamine may cause side effects like nausea or dizziness, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University General Hospital, Tianjin, 300052
Tianjin, China