Clinical TrialEsketamineNot yet recruiting

Effect and mechanism of low-dose esketamine on postoperative cognitive function in elderly non-cardiac patients with sleep disturbance

This parallel interventional trial in China (n=240) is assessing whether low-dose esketamine can reduce postoperative cognitive dysfunction in elderly non-cardiac surgical patients with sleep disturbance. Participants aged 65 years and older are allocated to an esketamine group (loading dose 0.25 mg/kg followed by 0.25 mg/kg/h infusion) or a control group receiving an equal volume of 0.9% normal saline. The study is focused on postoperative cognitive dysfunction, with the primary outcome being its incidence after surgery; the specific assessment timepoints are not reported in the available record. Secondary outcomes include haemodynamic stability, postoperative delirium, inflammatory and neural biomarkers (including IL-1β, IL-6, TNF-α, S100-β, HMGB1, RAGE and NfL), anxiety and depression scores, sleep quality, pain scores, depth of anaesthesia, vasoactive drug use, and postoperative nausea and vomiting. No trial phase is specified. The study is being conducted at Anhui No.2 Provincial People's Hospital in China.

Target Enrollment
Not specified
Study Type
Phase NA interventional
Design
Non-randomized

Study Arms & Interventions

Experimental

experimental

Esketamine group:Load 0.25mg/kg+0.25mg/kg/h pump;Control group:Equal volume 0.9% normal saline;

Interventions

  • Esketamine

    Extracted from ChiCTR intervention description

Participants

Ages
65?
Sexes
Male & Female

Inclusion Criteria

  • Inclusion criteria: 1. American Society of Anesthesiologists (ASA) II to III; 2. Non-cardiac surgery under tracheal intubation general anesthesia is planned; 3. Age >=65 years old; BMI (Body Mass Index) : 18-30kg/m^2; 4. Preoperative Pittsburgh Sleep Quality Index (PSQI) >=7 points or Athens Insomnia Scale (AIS) >=6 points; 5. Patients accepted the survey with good compliance, could complete the assessment and gave informed consent to participate

Exclusion Criteria

  • Exclusion criteria: 1. Allergies to any of the drugs used in the study; 2. The use of esketamine is contraindicated; 3. Liver and kidney dysfunction; 4. History of mental illness or use of psychotropic drugs; 5. A recent history of alcohol abuse; 6. Difficulty in verbal communication, significant hearing or visual impairment; 7. The preoperative Mini-mental State Examination (MMSE) score was <24 or the baseline cognitive assessment could not be completed

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Non-randomized
  • Timeline
    Start: 2025-11-03
  • Compound

Study Team

Sponsors & Collaborators

Locations

China

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