Esketamine: Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.
Normal Saline: An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
Study summary
To explore the effect of intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery
Eligibility
Sex
ALL
Min age
65 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Meet the diagnostic criteria for senile pruritus:
1. Aged ≥ 65 years old;
2. Presenting with only skin pruritus without obvious primary skin lesions, with or without scratch-induced skin lesions;
3. Daily or nearly daily pruritus lasting for more than 6 weeks.
2. Patients undergoing elective general anesthesia for orthopedic knee arthroplasty.
3. 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.
4. 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.
Exclusion Criteria:
1. Those who are allergic to the pharmaceutical ingredients of this study or have an allergic constitution;
2. Those with a history of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;
3. 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;
4. Patients with ASA physical status classification Grade IV-V;
5. 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;
6. Those with a history of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
7. Those with respiratory insufficiency or respiratory failure;
8. Those with BMI \< 18 kg/m² or BMI \> 30 kg/m²;
9. Those with poor compliance who cannot complete the trial in accordance with the research protocol;
10. Those who have participated in other clinical drug trials within the past 4 weeks;
11. Those deemed unsuitable for enrollment by the researchers for any reason. -
Primary outcome measure(s)
5D-IS score at 24 hours after surgery — 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.
Trial sites (1)
Facility
City
Region
Status
Tianjin Medical University General Hospital
Tianjin
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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