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NCT05718024
Night-time Dexmedetomidine-esketamine Infusion and Sleep Quality With Mechanical Ventilation
Conditions: Intensive Care Unit, Mechanical Ventilation, Dexmedetomidine, Esketamine, Sleep Quality
Sex: All
Ages: 50 Years – N/A
Phase: PHASE4
Enrollment: 174
Sponsor: Peking University First Hospital
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.
Eligibility 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.
Source: ClinicalTrials.gov (NCT05718024). StuddyBuddy aggregates publicly available trial information.