About this trial
To explore the effect of intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Esketamine
DrugEsketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.
Normal Saline
DrugAn equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
Intraoperative Anesthesia Information
Duration of anesthesia (minutes)
Intraoperative Vital Signs
Intraoperative average heart rate
Adverse Event
All kinds of adverse events(nausea, vomiting, respiratory depression, headache, dizziness, chills, delayed recovery from anesthesia) occurred in patients were recorded.
Intraoperative Anesthesia Information
Duration of surgery (minutes)
Sponsors and contacts
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