RecruitingPhase 3NCT07596589

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


Sponsor

Southeast University, China

Enrollment

80 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Remimazolam and a drug called propofol for people with mechanically ventilated icu patients, remimazolam besylate, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRemimazolam

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.

DRUGpropofol

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).


Locations(1)

Zhongda Hospital

Nanjing, Jiangsu, China

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NCT07596589


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