An interventional study of Esketamine and Normal Saline in Senile Pruritus, sponsored by Tianjin Medical University General Hospital. Not yet recruiting at 1 site in China. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Tianjin Medical University General Hospital · Not applicable, Interventional, and Treatment
To explore the effect of intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery
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.
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 422 interventional studies indexed under Pruritus.
Browse Pruritus studies →Tianjin Medical University General Hospital is the lead sponsor of 75 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meet the diagnostic criteria for senile pruritus:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
Drug: Normal Saline
Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.
Drug: Esketamine
Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.
An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
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.
Time frame: 24 hours after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours, 48 hours, 72 hours after the surgery
Intraoperative Anesthesia Information
Duration of anesthesia (minutes)
Time frame: Perioperative period
Intraoperative Vital Signs
Intraoperative average heart rate
Time frame: Perioperative period
Adverse Event
All kinds of adverse events(nausea, vomiting, respiratory depression, headache, dizziness, chills, delayed recovery from anesthesia) occurred in patients were recorded.
Time frame: 1 hour, 24 hours, 48 hours and 72 hours after surgery
Intraoperative Anesthesia Information
Duration of surgery (minutes)
Time frame: Perioperative period
Intraoperative Anesthesia Information
Intraoperative dosage of Sufentanil （μg）
Time frame: Perioperative period
Intraoperative Anesthesia Information
Intraoperative dosage of Remifentani (mg)
Time frame: Perioperative period
Intraoperative Vital Signs
intraoperative average blood oxygen saturation
Time frame: Perioperative period
Intraoperative Vital Signs
Mean Arterial Pressure（MAP）
Time frame: Perioperative period
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Jun 2027, 13 months later.
Of 85 non-industry interventional studies with no phase under Pruritus, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 14. This study's planned 13 months is above that.
Counting every sponsor, half of 101 studies reached it within 7 months; a quarter within 3 and three quarters within 13.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Esketamine
Tianjin Medical University General Hospital