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NCT Number: NCT07597486

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

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

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Key information

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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. -

Treatment and study plan

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.

Primary outcomes

  1. 5D-IS score at 24 hours after surgery

    Time frame: 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

  1. 5D-IS score at 48 hours,72 hours and the seventh day after surgery

    Time frame: 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.

  2. The incidence of pruritus on the 24 hours after surgery

    Time frame: 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.

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

    Time frame: 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.

  4. Pain Score (NRS)

    Time frame: 1 hours, 24 hours, 48 hours, 72 hours after the surgery

    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.

  5. The incidence of postoperative sleep disturbance on the first. second and third postoperative nights

    Time frame: the first,second and third nights after surgery

    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.

  6. Montreal Cognitive Assessment (MoCA)

    Time frame: 24 hours, 48 hours, 72 hours after the surgery

    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.

  7. Confusion Assessment Method (CAM)

    Time frame: 24 hours, 48 hours, 72 hours after the surgery

    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.

Other outcomes

  1. Intraoperative Anesthesia Information

    Time frame: Perioperative period

    Duration of anesthesia (minutes)

  2. Intraoperative Vital Signs

    Time frame: Perioperative period

    Intraoperative average heart rate

  3. Adverse Event

    Time frame: 1 hour, 24 hours, 48 hours and 72 hours after surgery

    All kinds of adverse events(nausea, vomiting, respiratory depression, headache, dizziness, chills, delayed recovery from anesthesia) occurred in patients were recorded.

  4. Intraoperative Anesthesia Information

    Time frame: Perioperative period

    Duration of surgery (minutes)

  5. Intraoperative Anesthesia Information

    Time frame: Perioperative period

    Intraoperative dosage of Sufentanil (μg)

  6. Intraoperative Anesthesia Information

    Time frame: Perioperative period

    Intraoperative dosage of Remifentani (mg)

  7. Intraoperative Vital Signs

    Time frame: Perioperative period

    intraoperative average blood oxygen saturation

  8. Intraoperative Vital Signs

    Time frame: Perioperative period

    Mean Arterial Pressure(MAP)

Study contacts

Contact information is provided by the study sponsor or research team.

Guolin Wang

CONTACT

[email protected]

15822855556

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients: A Single-Center Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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