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New drug cocktail may help ICU patients get better sleep

NCT ID NCT05718024

Symptom relief Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving a combination of two sedative drugs (dexmedetomidine and esketamine) at night can improve sleep quality for ICU patients who need a breathing tube or high-flow oxygen mask. The trial involved 174 adults aged 50 and older after surgery. Researchers measured sleep stages using brain wave monitoring to see if the drug combo helped patients spend more time in restorative sleep.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

174 people

The number who actually took part.

Started

Nov 2023

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dexmedetomidine Esketamine Intensive care unit Mechanical ventilation Sleep quality

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.