Senile PruritusNCT07597486
The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients
A study testing Esketamine and Normal Saline in people with Senile Pruritus, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
To explore the effect of intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Senile 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
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2026to 30 Sep 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Meet the diagnostic criteria for senile pruritus:
- Aged ≥ 65 years old;
- Presenting with only skin pruritus without obvious primary skin lesions, with or without scratch-induced skin lesions;
- Daily or nearly daily pruritus lasting for more than 6 weeks.
- Patients undergoing elective general anesthesia for orthopedic knee arthroplasty.
- Patients aged ≥ 65 years old, with ASA physical status classification Ⅰ-Ⅲ; BMI ranging from 18 to 30 kg/m², with no restriction on gender.
- Patients have fully understood the nature of this study, are capable of understanding and completing evaluation scales preoperatively, voluntarily participate in this trial, and sign the informed consent form.
Who cannot join
- Those who are allergic to the pharmaceutical ingredients of this study or have an allergic constitution;
- Those with a history of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
- Those with severe cognitive impairment, a history of neurological diseases, chronic pain, drug addiction, alcoholism, long-term opioid use, or administration of opioids within 48 hours before surgery;
- Patients with ASA physical status classification Grade IV-V;
- Those with severe coronary heart disease/arrhythmia/cardiac insufficiency, bronchial asthma, severe hypertension, severe hematopoietic system dysfunction, severe abnormal liver and kidney function, or significant electrolyte disorders;
- Those with a history of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
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- Those with respiratory insufficiency or respiratory failure;
- Those with BMI < 18 kg/m² or BMI > 30 kg/m²;
- Those with poor compliance who cannot complete the trial in accordance with the research protocol;
- Those who have participated in other clinical drug trials within the past 4 weeks;
- Those deemed unsuitable for enrollment by the researchers for any reason. -
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
Guolin Wang, +8618604755166, wangguolinhad@hotmail.com
About this study
Official title: The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients: A Single-Center Randomized Controlled Trial
To explore the effect of intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery
Read the detailed description
Pruritus (itching) is one of the most common clinical conditions in the elderly population. Its etiology is complex, and the prevalence gradually increases with age. Pruritus in the elderly not only imposes a significant disease burden but also severely affects their sleep quality and daily life. This chronic, persistent itching often disrupts the skin barrier function, easily creating a vicious itch-scratch cycle, which leads to multiple damages to the patient's quality of life.Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyHD-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief,rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an importantrole in the transmission of non-histaminergic itching. However, there is still a lack of reports on whether it can relieve pruritus symptoms in elderly patients. This experiment intends to investigate the effect of intraoperative esketamine infusion on skin pruritus in elderly surgical patients.
- Conditions
- Senile Pruritus
- Being tested
- Esketamine, Normal Saline
- Keywords
- esketamine, pruritus
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.
Normal SalineDrug
An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients with senile pruritus receive normal saline. | Placebo comparator | An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation. Receives: Drug: Normal Saline |
| Elderly patients with pruritus receive esketamine at a dose of 0.2 mg/kg. | Active comparator | Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation. Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
5D-IS score at 24 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: 24 hours after surgery
Secondary outcomes (7)
5D-IS score at 48 hours,72 hours and the seventh day 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: 48 hours,72 hours and the seventh day after surgery
The incidence of pruritus on the 24 hours after surgery
The 5D-IS score was completed by the patient 24 hours after the operation. The investigators recorded this score as a statistical indicator.
Measured: 24 hours after surgery
NRS pruritus score at 24 hours,48 hours and 72 hours after surgery
The patient evaluated the intensiy of prurtus wth 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; Extrermely severe itching.
Measured: 24 hours,48 hours and 72 hours 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 hours, 24 hours, 48 hours, 72 hours after the surgery
The incidence of postoperative sleep disturbance on the first. second and third postoperative nights
The patient completed the Sleep Quality Scale (AlS, Athens Insomnia Scale) one day before the surgery, There are a totat of 8 items in the AlS,with the score ranging from 0 to 24. A total score of 6 or above indicates a diagnosis of insomnia. We 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 AlS scores as statistical indicators.
Measured: the first,second and third nights after surgery
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment consists of 7 items, which evaluate visuospatial and executive function (5 points), naming (3 points), attention (6 points), language (3 points), abstract thinking (2 points), delayed recall (5 points), and orientation (6 points) respectively. A total score of ≥26 points indicates basically normal cognitive function; a total score of <25 points suggests cognitive decline.
Measured: 24 hours, 48 hours, 72 hours after the surgery
Confusion Assessment Method (CAM)
Confusion Assessment Method CAM is assessed based on four core features. Feature 1: Acute onset or fluctuating course; Feature 2: Inattention; Feature 3: Disorganized thinking; Feature 4: Altered level of consciousness. The diagnosis of delirium requires a positive result for Feature 1 + a positive result for Feature 2 + a positive result for either Feature 3 or Feature 4.
Measured: 24 hours, 48 hours, 72 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start15 May 2026 (estimated)
- Primary completion20 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Senile 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 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
- Investigators
- Guolin Wang, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07597486
- Sponsor's protocol ID
- IRB2025-YX-498-01
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 19 May 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients: A Single-Center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07597486
- Acronym / sponsor ID
- IRB2025-YX-498-01
- Conditions
- Senile Pruritus
- Keywords
- esketamine, pruritus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 May 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 intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery
Detailed description
Pruritus (itching) is one of the most common clinical conditions in the elderly population. Its etiology is complex, and the prevalence gradually increases with age. Pruritus in the elderly not only imposes a significant disease burden but also severely affects their sleep quality and daily life. This chronic, persistent itching often disrupts the skin barrier function, easily creating a vicious itch-scratch cycle, which leads to multiple damages to the patient's quality of life.Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyHD-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief,rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an importantrole in the transmission of non-histaminergic itching. However, there is still a lack of reports on whether it can relieve pruritus symptoms in elderly patients. This experiment intends to investigate the effect of intraoperative esketamine infusion on skin pruritus in elderly surgical patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly patients with senile pruritus receive normal saline. | Placebo comparator | Drug: Normal SalineAn equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation. |
| Elderly patients with pruritus receive esketamine at a dose of 0.2 mg/kg. | Active comparator | Drug: EsketamineEsketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Meet the diagnostic criteria for senile pruritus:
- Patients undergoing elective general anesthesia for orthopedic knee arthroplasty.
- Patients aged ≥ 65 years old, with ASA physical status classification Ⅰ-Ⅲ; BMI ranging from 18 to 30 kg/m², with no restriction on gender.
- Patients have fully understood the nature of this study, are capable of understanding and completing evaluation scales preoperatively, voluntarily participate in this trial, and sign the informed consent form.
Key exclusion criteria (11 listed)
- Those who are allergic to the pharmaceutical ingredients of this study or have an allergic constitution;
- Those with a history of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
- Those with severe cognitive impairment, a history of neurological diseases, chronic pain, drug addiction, alcoholism, long-term opioid use, or administration of opioids within 48 hours before surgery;
- Patients with ASA physical status classification Grade IV-V;
- Those with severe coronary heart disease/arrhythmia/cardiac insufficiency, bronchial asthma, severe hypertension, severe hematopoietic system dysfunction, severe abnormal liver and kidney function, or significant electrolyte disorders;
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 |
|---|---|---|
| EsketamineEsketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation. | Drug | Elderly patients with pruritus receive esketamine at a dose of 0.2 mg/kg. |
| Normal SalineAn equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation. | Drug | Elderly patients with senile pruritus receive normal saline. |
Primary outcome
5D-IS score at 24 hours after surgery
Time frame: 24 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.
7 secondary outcomes
5D-IS score at 48 hours,72 hours and the seventh day after surgery
Time frame: 48 hours,72 hours and the seventh day after surgery
The incidence of pruritus on the 24 hours after surgery
Time frame: 24 hours after surgery
NRS pruritus score at 24 hours,48 hours and 72 hours after surgery
Time frame: 24 hours,48 hours and 72 hours after surgery
Pain Score (NRS)
Time frame: 1 hours, 24 hours, 48 hours, 72 hours after the surgery
The incidence of postoperative sleep disturbance on the first. second and third postoperative nights
Time frame: the first,second and third nights after surgery
Montreal Cognitive Assessment (MoCA)
Time frame: 24 hours, 48 hours, 72 hours after the surgery
Confusion Assessment Method (CAM)
Time frame: 24 hours, 48 hours, 72 hours after the surgery
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 19 May 2026.
- Individual participant dataSharing planned: No
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.
Guolin Wang study director
Tianjin Medical University General Hospital
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 Senile 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 7 inclusion and 11 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 19 May 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 (15822855556, wangguolinhad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5D-IS score at 24 hours after surgery (time frame: 24 hours after surgery). 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 19 May 2026.