Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Sedation is a component of the care of critically ill patients who are undergoing mechanical ventilation. Dexmedetomidine induces sedation while preserving a degree of arousability among patients in the intensive care unit (ICU), and its use has resulted in a shorter time to extubation, an increased number of days free from coma or delirium, a reduced incidence of agitated delirium, prevention of delirium, and lower mortality than other agents administered in certain populations. Hypotension and bradycardia are common side effects, which is lethal for the patients with persistent or severe hemodynamic instability.

The pharmacological properties of rimazolom suggest that it is an ideal sedative drug for critically ill patients, but there is no relevant clinical research to confirm it. Therefore, this study mainly discusses the efficacy and safety of remidazolam in ICU patients with mechanical ventilation, so as to provide theoretical basis for individualized sedation treatment of patients with mechanical ventilation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients

NCT06575530

Effect of Drug Adverse Drug Event Mechanical Ventilation Complication +3 more

RECRUITING PHASE4

Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)

NCT00481312

Continuous Sedation in Initially Sedated Adults in ICU

COMPLETED PHASE3

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

NCT06124404

Mechanically Ventilated Patients

COMPLETED PHASE2

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

NCT05160987

Sedation and Analgesia

UNKNOWN NA

Low-dose Dexmedetomidine in Mechanically Ventilated ICU Patients

NCT03172897

Adult Disease Intensive Care Unit Syndrome Mechanical Ventilation Complication +2 more

SUSPENDED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. Title: Efficacy and Safety of Remimazolam for Sedation in ICU Patients Undergoing Mechanical Ventilation
2. Research center: Single Center
3. The Design of the study: Randomized, Controlled, Non-inferiority Trial
4. The population of the study: The main inclusion criteria are 18 years old or above, invasive mechanical ventilation is required, and the clinical need is mild to moderate Sedated (RASS score 0 to -3) patients
5. Sample size: Enroll 488 patients (244patients in each group)
6. Interventions: Participants in the test group received remimazolam for sedation, while participants in the control group received dexmedetomidine, The analgesia drug in two group is fentanyl.
7. The aim of the research: To investigate the efficacy and safety of remimazolam for sedation in ICU patients undergoing mechanical ventilation
8. Outcome# 1) Primary outcome# the ratio of the time to reach the target sedation (RASS score, 0 to -3)in the total duration of drug infusion, and the duration of mechanical ventilation. 2)Secondary outcome#; Length of stay in ICU and Length of stay in hospital; Incidence of complications (including re-hospitalization); Total expenses during hospitalization
9. The estimated duration of the study#2-3years

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Participants in the experimental group received remimazolam for sedation

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Remimazolam is used for sedation

Control group

participants in the control group received dexmedetomidine for sedation

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine is used for sedation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remimazolam

Remimazolam is used for sedation

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine is used for sedation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

1. Refuse to participate in this study
2. Patients with severe bradycardia (HR\<50 bpm)
3. Patients who is pregnancy
4. Patients with brain injury or neurosurgery
5. Patients receiving sedation for treatment indications (such as epilepsy), not to tolerate a ventilator.
6. Patients receiving any study medication within 30 days

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No