Night-time Dexmedetomidine-esketamine Infusion and Sleep Quality in ICU Patients (NCT05718024) | Clinical Trial Compass
CompletedPhase 4
Night-time Dexmedetomidine-esketamine Infusion and Sleep Quality in ICU Patients
China174 participantsStarted 2023-11-01
Plain-language summary
Dexmedetomidine and ketamine are both suggested for sedation and analgesia in ICU patients. 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 receiving mechanical ventilation or high-flow nasal cannula oxygen therapy in the ICU.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 50 years or older;
* Admitted to the intensive care unit (ICU) after surgery;
* Receiving mechanical ventilation or high-flow nasal cannula oxygen therapy during night-time (after 6 pm), with an expected duration of ≥12 hours.
Exclusion Criteria:
* Duration of invasive/non-invasive ventilation ≥12 hours before enrollment;
* Planning 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 mechanical ventilation or high-flow nasal cannula oxygen therapy;
* 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 last 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.
What they're measuring
1
Percentage of non-rapid eye movement sleep stage 2
Timeframe: From 21:00 pm to next 6:00 am during the first night after recruitment