Health TrialsbyHealthPanel

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

ConditionsRemimazolam BesylateMechanically Ventilated ICU PatientsSedation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSoutheast University, China

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Endotracheal intubation and mechanical ventilation for 24-96 hours before enrollment Expected need for continued invasive ventilation and sedation for at least 24 hours;

Target sedation depth on the Richmond Agitation-Sedation Scale (RASS) between 0 and -3;

Informed consent obtained from the patient's family

Disqualifiers

Body mass index (BMI) > 30 kg/m²

Severe central nervous system disease (e.g., acute stroke, uncontrolled seizures, or severe dementia) or any other condition that precludes RASS assessment

Mean arterial pressure (MAP) < 55 mmHg despite intravenous fluid resuscitation and vasopressors

Heart rate < 50 beats per minute, or second-degree or third-degree atrioventricular block in the absence of a pacemaker

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam

    Drug

    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.

  • propofol

    Drug

    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).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: remimazolamExperimental treatment 1 intervention
Group B: propofolActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day ventilator-free days

Time frame
28-day

Secondary outcomes

1

Incidence of delirium

Time frame
Up to 28 days
2

28-day shock-free days

Time frame
28-day
3

ICU length of stay

Time frame
Up to 30 days
4

hospital length of stay

Time frame
Up to 60 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southeast University, China

Lead sponsor

Source ClinicalTrials.gov
Apply now