The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorTianjin Medical University General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Esketamine

    Drug

    Esketamine 0.2 mg/kg is intravenously administered 30 minutes prior to the completion of the operation.

  • Normal Saline

    Drug

    An equal volume of normal saline is intravenously administered 30 minutes prior to the completion of the operation.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Elderly patients with senile pruritus receive normal saline.Placebo comparator 1 intervention
Group B: Elderly patients with pruritus receive esketamine at a dose of 0.2 mg/kg.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

Intraoperative Anesthesia Information

Duration of anesthesia (minutes)

Time frame
Perioperative period
2

Intraoperative Vital Signs

Intraoperative average heart rate

Time frame
Perioperative period
3

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
4

Intraoperative Anesthesia Information

Duration of surgery (minutes)

Time frame
Perioperative period

Sponsors and contacts

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