Cholestatic PruritusNCT07760740
The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery
A study testing Esketamine and normal Saline in people with Cholestatic Pruritus, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
To explore the effect of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholestatic Pruritus
- What is being tested?
- Esketamine and normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 20 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Medical University General Hospital, Tianjin, 300052
Tianjin
Guolin Wang, Study Director, +8615822855556, wangguolinghad@hotmail.com
About this study
Official title: 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
Read the detailed description
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
- Conditions
- Cholestatic Pruritus
- Being tested
- Esketamine, normal Saline
- Keywords
- cholestatic pruritus, esketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Continuous intraoperative infusion of esketamine at 0.3 mg/kg/h
normal SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving esketamine intervention | Active comparator | Patients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation. Receives: 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. Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: On the morning and evening of the second and third days after the operation
The incidence of sleep disorders on postoperative days 1-3
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.
Measured: The first, second and third days after the surgery
Postoperative anxiety
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
Measured: 1 day before surgery ,1 -3 days after surgery
Postoperative depression
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.
Measured: 1 day before surgery ,1 -3 days after surgery
Pain Score (NRS)
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.
Measured: 1-3 days after surgery
5-D itch scale at 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
Measured: 72 hours after surgery
Liver function tests (LFTs)
- Alanine Transaminase, ALT
- Aspartate Aminotransferase, AST
- Total Bilirubin, TBil
- Direct Bilirubin, DBIL
- Alkaline phosphatase, ALP
- Gamma-glutamyltransferase, GGT
Measured: Preoperative baseline and postoperative day one
Postoperative Complications
- Nausea and vomiting
- Dizziness
- Nightmare
- Respiratory depression
- hallucinations
Measured: Within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholestatic PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760740
- Sponsor's protocol ID
- IRB2025-YX-497-01
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Infusion of Esketamine on Cholestatic Pruritus in Patients Undergoing Hepatobiliary Surgery: A Single-center Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07760740
- Acronym / sponsor ID
- IRB2025-YX-497-01
- Conditions
- Cholestatic Pruritus
- Keywords
- cholestatic pruritus, esketamine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the effect of esketamine on cholestatic pruritus in patients undergoing hepatobiliary surgery
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving esketamine intervention | Active comparator | Drug: EsketaminePatients undergoing hepatobiliary surgery and suffering from cholestatic pruritus received continuous infusion of esketamine during the operation. |
| Patients receiving an equal volume of saline | Placebo comparator | Drug: normal SalinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Inclusion Criteria:
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineContinuous intraoperative infusion of esketamine at 0.3 mg/kg/h | Drug | Patients receiving esketamine intervention |
| normal SalinePatients 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 | Patients receiving an equal volume of saline |
Primary outcome
NRS scores for pruritus assessed in the morning and evening on postoperative day 1
Time frame: 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.
8 secondary outcomes
The NRS scores for pruritus in the morning and evening on the second and third days after the operation.
Time frame: On the morning and evening of the second and third days after the operation
The incidence of sleep disorders on postoperative days 1-3
Time frame: The first, second and third days after the surgery
Postoperative anxiety
Time frame: 1 day before surgery ,1 -3 days after surgery
Postoperative depression
Time frame: 1 day before surgery ,1 -3 days after surgery
Pain Score (NRS)
Time frame: 1-3 days after surgery
5-D itch scale at 72 hours after surgery
Time frame: 72 hours after surgery
Liver function tests (LFTs)
Time frame: Preoperative baseline and postoperative day one
Postoperative Complications
Time frame: Within 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Cholestatic Pruritus
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
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Not yet recruitingPhase 3
J-LINX: Japan LINerixibat eXtension Study
Pruritus
Active, not recruitingPhase 3
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)
Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC)
Not yet recruitingPhase 2
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Chronic Hepatic Pruritus, Cholestatic Liver Disease
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Primary Biliary Cholangitis, PBC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and normal Saline in people with Cholestatic Pruritus, run by Tianjin Medical University General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guolin Wang, Study Director (+8615822855556, wangguolinghad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS scores for pruritus assessed in the morning and evening on postoperative day 1 (time frame: The morning and evening of the first day after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.