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

NCT06124404 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-19

No results posted yet for this 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.

Conditions

  • Mechanically Ventilated Patients

Interventions

DRUG

Remimazolam besylate

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

DRUG

Remimazolam besylate

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

DRUG

Remimazolam besylate

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

Sponsors & Collaborators

  • Yichang Humanwell Pharmaceutical Co., Ltd., China

    collaborator INDUSTRY

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06124404 on ClinicalTrials.gov