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 range

50 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT05718024

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-22

View on ClinicalTrials.gov More Intensive Care Unit trials