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

NCT07596589 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Remimazolam Besylate
  • Mechanically Ventilated ICU Patients
  • Sedation

Interventions

DRUG

Remimazolam

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.

DRUG

propofol

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).

Sponsors & Collaborators

  • Southeast University, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-01-31
Completion
2027-01-31

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 NCT07596589 on ClinicalTrials.gov