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

NCT07597486 | Not Yet Recruiting

• 1 other identifier: IRB2025-YX-498-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the effect of intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery

Conditions

Senile Pruritus

Keywords

esketamine; pruritus

Outcome Measures

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.

  24 hours after surgery

Secondary Outcomes (7)

• 5D-IS score at 48 hours,72 hours and the seventh day after surgery

  48 hours,72 hours and the seventh day after surgery

• The incidence of pruritus on the 24 hours after surgery

  24 hours after surgery

• NRS pruritus score at 24 hours,48 hours and 72 hours after surgery

  24 hours,48 hours and 72 hours after surgery

• Pain Score (NRS)

  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 first,second and third nights after surgery

Other Outcomes (8)

• Intraoperative Anesthesia Information

  Perioperative period

• Intraoperative Vital Signs

  Perioperative period

• Adverse Event

  1 hour, 24 hours, 48 hours and 72 hours after surgery

Study Arms (2)

Elderly patients with senile pruritus receive normal saline.

PLACEBO COMPARATOR

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

Drug: Normal Saline

Elderly patients with pruritus receive esketamine at a dose of 0.2 mg/kg.

ACTIVE COMPARATOR

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

Drug: Esketamine

Interventions

Esketamine DRUG

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

Elderly patients with pruritus receive esketamine at a dose of 0.2 mg/kg.

Normal Saline DRUG

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

Elderly patients with senile pruritus receive normal saline.

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria for senile pruritus:
• 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.
• 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.
• 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.

You may not qualify if:

• 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;
• 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;
• Those with a history of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);
• Those with respiratory insufficiency or respiratory failure;
• Those with BMI \< 18 kg/m² or BMI \> 30 kg/m²;
• Those with poor compliance who cannot complete the trial in accordance with the research protocol;
• Those who have participated in other clinical drug trials within the past 4 weeks;
• Those deemed unsuitable for enrollment by the researchers for any reason. -

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

MeSH Terms

Conditions

Pruritus

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Guolin Wang

  Tianjin Medical University General Hospital

  STUDY DIRECTOR

Central Study Contacts

Guolin Wang

CONTACT

15822855556; wangguolinhad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 19, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)