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

A Multicenter, Randomized, Single-blinded, Parallel, Two-step Trial to Evaluate the Effectiveness and Safety of Remimazolam Besylate for Injection for Sedation in ICU Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06124404

Enrollment

Registered

2023-11-09

Start date

2022-04-08

Completion date

2023-02-28

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanically Ventilated Patients

Brief 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.

Interventions

DRUGRemimazolam besylate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
The percentage of time in the target sedation range without rescue sedation	Within 24 hours while receiving the study drug	The percentage of time in the target sedation range without rescue sedation

Secondary

Measure	Time frame	Description
Adverse drug reactions (ADRs)	24 hours	Adverse drug reactions (ADRs)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026