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Remimazolam BesylatePhase 3NCT07596589

Effect of Remimazolam Sedation on Outcomes of Mechanically Ventilated Patients in the ICU

A Phase 3 study testing Remimazolam and propofol in people with Remimazolam Besylate and Mechanically Ventilated ICU Patients, run by Southeast University, China at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients through a single-center, prospective, randomized controlled, pilot study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Remimazolam and propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Apr 2025to 31 Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years;
  • Endotracheal intubation and mechanical ventilation for 24-96 hours before enrollment Expected need for continued invasive ventilation and sedation for at least 24 hours;
  • Target sedation depth on the Richmond Agitation-Sedation Scale (RASS) between 0 and -3;
  • Informed consent obtained from the patient's family

Who cannot join

  • Body mass index (BMI) > 30 kg/m²
  • Severe central nervous system disease (e.g., acute stroke, uncontrolled seizures, or severe dementia) or any other condition that precludes RASS assessment
  • Mean arterial pressure (MAP) < 55 mmHg despite intravenous fluid resuscitation and vasopressors
  • Heart rate < 50 beats per minute, or second-degree or third-degree atrioventricular block in the absence of a pacemaker
  • Acute myocardial infarction or severe heart failure (New York Heart Association [NYHA] class IV)
  • Left ventricular ejection fraction < 30%
Show all 13Show fewer
  • Any contraindication or allergy to benzodiazepines
  • Substance dependence, alcohol abuse, or psychiatric/psychological disorders. Alcohol abuse was defined as regular consumption of > 14 drinks per week (1 drink = 150 mL wine, 360 mL beer, or 45 mL liquor)
  • Acute hepatitis or severe hepatic dysfunction (Child-Pugh class C)
  • Chronic kidney disease with a glomerular filtration rate (GFR) < 60 mL/min/1.73 m²
  • Neuromuscular disease
  • Patients on extracorporeal membrane oxygenation (ECMO)
  • Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jingyuan Xu, M.D. contact

00862583262500

xujingyuanmail@163.com

China1 site, 1 recruiting
  • Zhongda Hospital

    Nanjing, Jiangsu, 210009

    Jingyuan Xu, M.D., 00862583262500, xujingyuanmail@163.com

    Recruiting

Other trials in China

About this study

The goal of this clinical trial is to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients through a single-center, prospective, randomized controlled, pilot study.

Read the detailed description

Worldwide, approximately 13-20 million patients receive mechanical ventilation in intensive care units (ICUs) each year. As a crucial life-support modality, mechanical ventilation is widely used for the management of respiratory failure due to various causes, as well as for respiratory support during anesthesia and after surgery. However, mechanical ventilation may also induce anxiety, pain, and patient-ventilator asynchrony, leading to increased oxygen consumption, a higher risk of barotrauma, and potentially worse patient outcomes. Therefore, patients undergoing mechanical ventilation usually require sedatives to improve comfort and safety, reduce anxiety, optimize ventilation efficacy, and decrease the incidence of complications.

In current clinical practice, various sedatives such as midazolam, propofol, and dexmedetomidine are widely used, all of which can effectively achieve sedation. Midazolam is a classic benzodiazepine sedative widely used in the ICU. It exerts central inhibitory effects by enhancing γ-GABA-mediated neurotransmission, thereby producing sedation, anxiolysis, and anterograde amnesia. However, it has a relatively slow onset and tends to accumulate in the body, leading to prolonged recovery time. Propofol is known for its rapid onset, short duration of action, and quick recovery after discontinuation. Its depth of sedation is positively correlated with the administered dose. Nevertheless, propofol may increase hemodynamic instability by reducing vascular tone and decreasing venous return, and it also exerts respiratory depression. Moreover, high-dose or long-term use of propofol can potentially cause fatal propofol infusion syndrome. Dexmedetomidine, a selective α2-adrenergic receptor agonist, reduces sympathetic overactivity by inhibiting norepinephrine release from the locus coeruleus and competitively binding to α2 receptors, thereby producing sedation, anxiolysis, and mild analgesia. Patients sedated with dexmedetomidine are relatively easy to arouse and have a lower incidence of respiratory depression, but this drug tends to cause hypotension and bradycardia.

Remimazolam, a novel ultra-short-acting benzodiazepine sedative, exerts its sedative effects by binding to and enhancing the activity of GABAA receptors, thereby reducing neuronal excitability. It features rapid onset, predictable sedative effect, lack of accumulation in the body, quick metabolism, mild cardiorespiratory depression, and low dependence on hepatic and renal function. The sedative effect of remimazolam can be reversed by the specific benzodiazepine antagonist flumazenil. Given these properties, remimazolam is considered an ideal sedative in the ICU and an excellent choice for sedation in critically ill patients. In recent years, it has been gradually applied in procedural sedation and general anesthesia. In a multicenter, randomized, single-blind, non-inferiority trial of mechanically ventilated ICU patients, remimazolam was found to be non-inferior to propofol in achieving short-term light sedation. In addition, a preliminary study by Tang Y and colleagues showed that remimazolam was similarly effective and safe for long-term sedation in mechanically ventilated ICU patients compared with propofol [10].

As an emerging drug, remimazolam has a relatively short history of clinical use. Current research on this drug is mainly concentrated in the fields of endoscopy and anesthesiology, with relatively few studies focusing on its sedative application in ICU patients. Therefore, the aim of this study was to evaluate the effect of ective, randomized controlled, pilot study was conducted to evaluate the effect of remimazolam sedation on outcomes of mechanically ventilated ICU patients.

Being tested
Remimazolam, propofol
Keywords
remimazolam, sedation, ICU

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemimazolamDrug

    In the intervention group, patients with a Richmond Agitation-Sedation Scale (RASS) score of -3 to 0 were given remimazolam besylate for injection at a loading dose of 0.08 mg/kg infused intravenously over 10 min, followed by a continuous infusion at a rate of 0.2 mg/kg/h. When dose adjustment was required, each step was 0.1-0.2 mg/kg/h, with a dose range of 0-2 mg/kg/h, until the target sedation level (RASS: -3 to 0) was achieved. If the target sedation level was not reached, an additional bolus dose of 0.08 mg/kg remimazolam besylate could be administered.

  • propofolDrug

    In the control group, patients received propofol emulsion injection at a loading dose of 0.3 mg/kg/h injected over 1 min, followed by a continuous infusion at a rate of 0.3 mg/kg/h. Dose adjustments were made in increments of 0.3-0.6 mg/kg/h, within a dose range of 0.3-4 mg/kg/h, to achieve the target sedation level (RASS: -3 to 0).

Study groups in NCT07596589
Study groupRoleWhat they receive
remimazolamExperimentalNot described
Receives: Drug: Remimazolam
propofolActive comparatorNot described
Receives: Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day ventilator-free days

    Measured: 28-day

Secondary outcomes (5)
  1. Incidence of delirium

    Measured: Up to 28 days

  2. 28-day shock-free days

    Measured: 28-day

  3. ICU length of stay

    Measured: Up to 30 days

  4. hospital length of stay

    Measured: Up to 60 days

  5. 28-day mortality

    Measured: 28-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2026
  2. Study start1 Apr 2025
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07596589
Sponsor's protocol ID
2022ZDSYLL327-P01
Status last verified
May 2026
First submitted
6 May 2026
Last updated
19 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remimazolam and propofol in people with Remimazolam Besylate and Mechanically Ventilated ICU Patients, run by Southeast University, China at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jingyuan Xu, M.D. (00862583262500, xujingyuanmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day ventilator-free days (time frame: 28-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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