Night-time Dexmedetomidine-esketamine Infusion and Sleep Quality With Mechanical Ventilation

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Dexmedetomidine and ketamine are both suggested for sedation and analgesia in ICU patients with mechanical ventilation. Recent studies suggest that low-dose dexmedetomidine or ketamine/esketamine may improve sleep quality of ICU patients. The purpose of this trial is to observe whether night-time infusion of low-dose dexmedetomidine-esketamine combination can improve sleep structure of patients with mechanical ventilation in the ICU.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Treatments: Dexmedetomidine; Esketamine; Propofol; Remifentanil

Criteria

Inclusion Criteria:

• Aged 50 years or older;

• Receiving invasive mechanical ventilation or non-invasive auxiliary ventilation in the ICU, with an estimated duration of ≥24 hours;

• Sedation is necessary as judged by the intensivists.

Exclusion Criteria:

• Duration of invasive/non-invasive ventilation ≥12 hours before enrollment;

• Plan to receive muscle relaxant treatment;

• History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;

• Unable to communicate due to coma, delirium, severe dementia, or language barrier before receiving invasive/non-invasive ventilation;

• Acute stroke or hypoxic encephalopathy, or after craniocerebral injury or neurosurgery;

• Comorbid with hyperthyroidism or pheochromocytoma;

• Taking sedative/hypnotic drugs or analgesics regularly (for more than 1 week) in the past month;

• LVEF<30%; sick sinus syndrome, severe sinus bradycardia (heart rate<50 beats/min), atrioventricular block of more than II degree and without pacemaker; or systolic blood pressure <90 mmHg despite vasopressor infusion;

• Severe liver dysfunction (Child-Pugh C grade), severe renal dysfunction (dialysis), or estimated survival ≤24 hours;

• Diagnosed obstructive sleep apnea, or body mass index >30 kg/m2;

• Allergies to dexmedetomidine and/or esketamine, or other conditions that are considered unsuitable for study participation;

• Enrolled in other clinical studies.