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.
Meet the diagnostic criteria for senile pruritus:
Exclusion Criteria:
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
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Tianjin Medical University General Hospital