Improving sleep quality in ICU patients on mechanical ventilation with a medication combination

Impact of Night-time Dexmedetomidine-esketamine Infusion on Sleep Quality of Patients With Mechanical Ventilation in ICU: a Randomized Controlled Trial

This study tests if a low-dose combination of two medications can help improve sleep quality for patients on mechanical ventilation in the ICU.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 174 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05718024 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of a night-time infusion of a low-dose combination of dexmedetomidine and esketamine on sleep quality in patients undergoing mechanical ventilation in the ICU. The study aims to determine if this combination can enhance sleep structure while minimizing adverse effects compared to higher doses of these medications. Given the common sleep disturbances in ICU patients, the trial seeks to address the negative outcomes associated with poor sleep, such as increased pain sensitivity and risk of delirium. The safety of this regimen will also be evaluated throughout the study.

Who should consider this trial

Good fit: Ideal candidates are patients aged 50 years or older who require invasive or non-invasive mechanical ventilation in the ICU for at least 24 hours.

Not a fit: Patients with a history of certain neurological disorders or those unable to communicate due to severe cognitive impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve sleep quality and overall outcomes for ICU patients on mechanical ventilation.

How similar studies have performed: Previous studies have shown promising results with similar approaches, suggesting potential for improved sleep quality in ICU patients.

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.

Where this trial is running

Beijing, Beijing

• Peking University First Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
• Study coordinator: Dong-Xin Wang, MD, PhD

Conditions: Intensive Care Unit, Mechanical Ventilation, Dexmedetomidine, Esketamine, Sleep Quality, Intensive care unit, Mechanical ventilation, Sleep quality