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CompletedNCT06124404Updated Mar 19, 2026

Step 1 of A Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Sedation in ICU Patients

A Phase 2 interventional study of Remimazolam besylate and Remimazolam besylate in Mechanically Ventilated Patients, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Phase 2, Interventional, and Other

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Apr 2022, registered Sep 2023).
Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This is a Phase II, dose-escalation clinical trial conducted in mechanically ventilated patients receiving sedation no longer than 24 hours. The efficacy, safety, and pharmacokinetics of remimazolam besylate were evaluated using a randomized, single-blind design.

02

Conditions studied

  • Mechanically Ventilated Patients
03

In context

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 160 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body mass index (BMI) ≥18 and ≤ 30 kg/m2
  • Being Intubated and mechanically ventilated ≤48 hours before enrollment and expected to be on a ventilator for at least 6 hours
  • Requirement for light to moderate sedation (a Richmond agitation-sedation scale score of -2 to 1)

Exclusion criteria

Exclusion Criteria:

  • Refusal to be included
  • Allergy or unsuitability to any composition of study drugs or remifentanil
  • Living expectancy less than 48 hours
  • Myasthenia gravis
  • Status asthmaticus
  • Abdominal compartment syndrome
  • Serious hepatic dysfunction (CTP 10-15);
  • Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2
  • Mean blood pressure less than 65 mm Hg or the need for a continuous infusion of norepinephrine at ≥0.5 ug/kg/min to maintain Mean blood pressure ≥ 65 mm Hg
  • Possible requirement for surgery or bedside tracheostomy in 24 hours
  • Possible requirement for renal replacement therapy in 24 hours
  • Acute severe neurological disorder and any other condition interfering with sedation assessment
  • Abuse of controlled substances or alcohol
  • Pregnancy or lactation
05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Small dose

    Drug: Remimazolam besylate

  • Experimental
    Medium dose

    Drug: Remimazolam besylate

  • Experimental
    Large dose

    Drug: Remimazolam besylate

Interventions

  • DrugRemimazolam besylate

    After a loading dose of 0.08mg/kg, a maintaining dose of 0.1mg/kg/h is given

    Also known as: A maintaining dose of 0.1mg/kg/h

  • DrugRemimazolam besylate

    After a loading dose of 0.08mg/kg, a maintaining dose of 0.2mg/kg/h is given

    Also known as: A maintaining dose of 0.2mg/kg/h

  • DrugRemimazolam besylate

    After a loading dose of 0.08mg/kg, a maintaining dose of 0.4mg/kg/h is given

    Also known as: A maintaining dose of 0.4mg/kg/h

06

What researchers measure

Primary outcomes

  1. The percentage of time in the target sedation range without rescue sedation

    The percentage of time in the target sedation range without rescue sedation

    Time frame: Within 24 hours while receiving the study drug

Secondary outcomes

  1. Adverse drug reactions (ADRs)

    Adverse drug reactions (ADRs)

    Time frame: 24 hours

07

Study locations

1 site
  • Wuhan Union Hospital
    Wuhan, Hubei 430022, China
08

References and documents

Publications

  • Yang X, Fu S, Yu L, Liang F, Li D, Sun R, Zhou X, Yu X, Tian L, Shang Y. Efficacy and safety of remimazolam besylate in patients receiving mechanical ventilation: A randomized phase Ⅱa trial. J Intensive Med. 2026 Jan 8;6(3):277-283. doi: 10.1016/j.jointm.2025.12.002. eCollection 2026 Jun. PubMed 42164587 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06124404
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators
Yichang Humanwell Pharmaceutical Co., Ltd., China
Responsible party
Sponsor
First posted
Nov 9, 2023
Start date
Apr 8, 2022
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023
Last update
Mar 19, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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