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New sedative could keep ICU patients calmer on ventilators

NCT ID NCT06575530

Symptom relief Sponsor: Beijing Shijitan Hospital, Capital Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether remimazolam besylate works as well as dexmedetomidine for keeping patients lightly sedated while on a breathing machine after non-cardiac surgery. About 306 adults aged 18–64 will take part across five hospitals in China. The goal is to see if remimazolam can safely provide steady sedation without causing more side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remimazolam besylate
What this could lead to
If it works, this could offer a safer or equally effective sedation option for ICU patients on breathing machines after surgery.
What could go wrong
This is a Phase 4 trial, but it only compares two sedatives—not a breakthrough. Results may not apply to all ICU patients or surgeries.

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

About 306 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

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

18 to 64 years

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 between 18 and 64 years * Scheduled to undergo elective non-cardiac surgery * Planned for general anesthesia * With or without combined regional nerve blockade * Admitted to the ICU with endotracheal intubation post-surgery * With an anticipated duration of postoperative mechanical ventilation greater than 24 hours * Clinically requiring light sedation( target RASS score 0 to -2) Exclusion Criteria: * Undergoing intracranial surgery, or having a history of severe neurological or spinal cord diseases * Pre-existing history of schizophrenia, epilepsy, or Parkinson's disease * Inability to communicate preoperatively due to coma, severe dementia, or language barriers * Preoperative .cardiac insufficiency or severe cardiac arrhythmias * Severe hepatic impariment( Child-Pugh class C) * Severe renal impariment * Preoperative( within 24 hours prior to surgery) or intraoperative administration of dexmedetomidine or remimazolam * Pregnancy or lactation * Participation in any clinical trial involving investigational drugs within 30 days prior to enrollment * Any other conditions deemed by the investigators to render the patient unsuitable for study participation * Refusal to provide written informed consent

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Conditions

The condition(s) this trial relates to.

Critical Illness Drug-Related Side Effects and Adverse Reactions

As listed by the trial registrant

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

Adverse drug event Critical illness Effect of drug Mechanical ventilation complication Sedation Surgery

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Shijitan Hospital.CMU

    RECRUITING

    Beijing, Beijing Municipality, 100038, China

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