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Effect of Remimazolam With Protocolized Sedation on Critical Ill, Mechanical Ventilated Patients Compared With Midazolam

ConditionSedation and Analgesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZhujiang Hospital

About this trial

In this parallel, multicenter, single-blind randomized controlled trial, mechanical ventilated patients will be randomly assigned to two groups. One receives remimazolam to achieve sedation goals, while the other receives Midazolam. The primary outcome is the effect of remimazolam on duration of mechanical ventilated of critical patients compared to midazolam.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Critical ill patients that are mechanically ventilated within the first 48h of admission to the ICU and who would remain in the ICU for over 72h were enrolled in this study.

Age 18-80 years.

Voluntary informed consent.

Disqualifiers

Surgical treatment is performed within 24 hours.

Craniocerebral injury, post neurosurgery, non drug coma, mental illness or peripheral neuropathy.

Heart rates are less than 50 beats / min or severe atrioventricular block without pacemaker support.

The mean arterial pressure is less than 55 mmHg even though fluids and vasoactive drugs are administrated.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Remimazolam

    Drug

    Remimazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.

  • Midazolam

    Drug

    Midazolam will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Remimazolam GroupExperimental treatment 1 intervention
Group B: Midazolam GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of mechanical ventilation

Weaning success is typically regarded as consecutive ventilator-free over 24h following liberation from a ventilator. The duration of mechanical ventilation is from the enrollment time to the weaning time. The study and observation would be stopped due to difficult ventilator weaning, which features weaning failure repeatedly for 3 weeks.

Time frame
From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days

Secondary outcomes

1

Duration of endotracheal intubation

Duration of endotracheal intubation

Time frame
From the date of enrollment until the date of pulling out the endotracheal tube, assessed up to 28 days
2

Completion rate of sedation goal

completion rate of sedation goal = days of achieving sedation goals / total days of sedation (days from enrollment to successful ventilator withdrawal) × 100%

Time frame
From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
3

Remediation is defined as requiring combination with other sedations

If the sedation goal cannot be reached, the clinician will use non benzodiazepines according to the actual situation of the patient, and record the medication and dosage.

Time frame
From the date of enrollment until the date of successful ventilator withdrawal, assessed up to 28 days
4

Length of stay in ICU and total length of stay

Length of stay in ICU and total length of stay

Time frame
From the date of admission in ICU until the date of transfer from ICU

Other outcomes

Sponsors and contacts

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Zhujiang Hospital

Lead sponsor

Integrated traditional Chinese and Western Medicine Hospital of Southern Medical University

Collaborator

First Affiliated Hospital of Shantou University Medical College

Collaborator

Affiliated Hospital of Guangdong Medical University

Collaborator

Yunfu People's Hospital

Collaborator

Zhongshan Hospital Of Traditional Chinese Medicine

Collaborator

Guangdong Province Traditional Medical hospital

Collaborator

The Third Affiliated Hospital of Guangzhou Medical University

Collaborator

Source ClinicalTrials.gov
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